FDA 510(k) Applications for Medical Device Product Code "MCW"
(Catheter, Peripheral, Atherectomy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990829 | ARROW INTL., INC. | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 | 05/04/1999 |
| K970080 | ARROW INTL., INC. | ARROW-TREROTOLA PTD CATHETER | 07/25/1997 |
| K140944 | ATHEROMED INC | 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP | 08/22/2014 |
| K132682 | ATHEROMED INC | PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA | 01/17/2014 |
| K162326 | Avinger, Inc | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | 10/18/2016 |
| K160827 | AVINGER, INC. | Pantheris Catheter | 04/21/2016 |
| K172236 | Avinger, Inc. | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | 10/30/2017 |
| K163264 | Avinger, Inc. | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | 12/21/2016 |
| K153460 | AVINGER, INC. | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | 03/01/2016 |
| K230005 | Avinger, Inc. | Pantheris LV Atherectomy Catheter | 06/06/2023 |
| K182341 | Avinger, Inc. | Pantheris SV | 04/09/2019 |
| K152275 | Avinger, Inc. | Pantheris System | 10/14/2015 |
| K173862 | Avinger, Inc. | Pantheris System | 05/22/2018 |
| K212047 | Avinger, Inc. | Pantheris System | 11/16/2021 |
| K003570 | BACCHUS VASCULAR, INC. | BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 | 06/06/2001 |
| K022640 | BACCHUS VASCULAR, INC. | SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM | 12/02/2002 |
| K033997 | BACCHUS VASCULAR, INC. | SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 | 02/04/2004 |
| K242757 | Bard Peripheral Vascular, Inc. | Rotarex Atherectomy System | 01/30/2025 |
| K993816 | BAXTER EDWARDS | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD | 05/04/2000 |
| K982363 | BOSTON SCIENTIFIC CORP. | OASIS THROMBECTOMY CATHETER SYSTEM | 02/23/1999 |
| K970296 | BOSTON SCIENTIFIC CORP. | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER | 08/29/1997 |
| K121774 | BOSTON SCIENTIFIC CORP. | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS | 09/13/2012 |
| K133566 | BOSTON SCIENTIFIC CORP. | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS | 12/20/2013 |
| K220962 | Boston Scientific Corporation | ROTAPRO Rotational Atherectomy System | 09/06/2022 |
| K993648 | BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER | 11/24/1999 |
| K211738 | C.R. Bard, Inc. | Rotarex Atherectomy System | 09/14/2021 |
| K233483 | Cardio Flow Inc. | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | 02/15/2024 |
| K250723 | Cardio Flow Inc. | FreedomFlowÖ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | 04/25/2025 |
| K231538 | Cardio Flow, Inc. | FreedomFlow Orbital Circumferential Atherectomy System | 09/27/2023 |
| K242947 | Cardio Flow, Inc. | FreedomFlowÖ Orbital Circumferential Atherectomy System | 11/05/2024 |
| K081944 | CARDIO SYSTEMS, INC. | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | 08/14/2008 |
| K131092 | CARDIO SYSTEMS, INC. | STEALTH 360 ORBITAL PAD SYSTEM | 06/24/2013 |
| K220568 | Cardiovascualr Systems Inc. | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | 04/27/2022 |
| K151260 | Cardiovascular System, Inc. | ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD | 06/10/2015 |
| K210586 | Cardiovascular Systems Inc. | Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system | 09/14/2021 |
| K152694 | Cardiovascular Systems Inc. | Diamondback 360 Peripheral Orbital Atherectomy System | 10/21/2015 |
| K182397 | Cardiovascular Systems Inc. | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series | 12/13/2018 |
| K203008 | Cardiovascular Systems Inc. | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | 11/19/2020 |
| K220109 | Cardiovascular Systems Inc. | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | 03/01/2022 |
| K190634 | Cardiovascular Systems Inc. | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | 07/02/2019 |
| K180416 | Cardiovascular Systems Inc. | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System | 04/17/2018 |
| K133399 | CARDIOVASCULAR SYSTEMS INCORPORATED | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | 11/22/2013 |
| K041630 | CARDIOVASCULAR SYSTEMS INCORPORATED | ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS | 01/31/2005 |
| K090521 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 DBX | 03/20/2009 |
| K072800 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | 10/25/2007 |
| K071350 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | 08/22/2007 |
| K071427 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS | 08/30/2007 |
| K082981 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT | 10/31/2008 |
| K170792 | Cardiovascular Systems, Inc. | Diamondback 360 Peripheral Orbital Atherectomy System | 06/09/2017 |
| K133999 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM | 02/28/2014 |
| K150732 | CARDIOVASCULAR SYSTEMS, INC. | Diamondback 360 Peripheral Orbital Atherectomy System | 04/13/2015 |
| K111388 | CARDIOVASCULAR SYSTEMS, INC. | DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM | 07/26/2011 |
| K072748 | CARDIOVASCULAR SYSTEMS, INC. | MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM | 11/09/2007 |
| K110389 | CARDIOVASCULAR SYSTEMS, INC. | STEALTH 360 ORBITAL PAD SYSTEM | 03/11/2011 |
| K122987 | CARDIOVASCULAR SYSTEMS, INC. | STEALTH 360 ORBITAL PAD SYSTEM | 10/25/2012 |
| K141801 | COVIDIEN, LLC | HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM | 10/16/2014 |
| K021096 | EV3 CORPORATION | X-SIZER CATHETER SYSTEM | 09/08/2004 |
| K093301 | EV3 INC | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | 11/06/2009 |
| K111723 | EV3 INC | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | 10/27/2011 |
| K103618 | EV3 INC | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM | 01/05/2011 |
| K220116 | Eximo Medical Ltd. | Auryon Atherectomy Catheters | 09/26/2022 |
| K202835 | Eximo Medical Ltd. | Auryon Atherectomy System | 12/02/2020 |
| K221077 | Eximo Medical Ltd. | Auryon Atherectomy System | 06/09/2022 |
| K230709 | Eximo Medical Ltd. | Auryon Atherectomy System | 06/09/2023 |
| K181642 | Eximo Medical Ltd. | B-Laser Atherectomy System | 10/05/2018 |
| K233668 | Eximo Medical, Ltd. | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011 | 12/15/2023 |
| K241553 | Eximo Medical, Ltd. | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | 06/27/2024 |
| K053460 | FOX HOLLOW TECHNOLOGIES | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, | 01/13/2006 |
| K024243 | FOX HOLLOW TECHNOLOGIES | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 | 06/20/2003 |
| K043553 | FOX HOLLOW TECHNOLOGIES | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 | 02/18/2005 |
| K071432 | FOX HOLLOW TECHNOLOGIES | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE | 02/12/2008 |
| K061063 | FOXHOLLOW TECHNOLOGIES, INC. | MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 | 05/18/2006 |
| K061188 | FOXHOLLOW TECHNOLOGIES, INC. | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | 10/23/2006 |
| K970233 | GARY A. GELBFISH | GELBFISH ENDO-VAC SYSTEM | 10/08/1997 |
| K954604 | HEART TECHNOLOGY MFG., INC. | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY | 01/18/1996 |
| K960379 | HEART TECHNOLOGY MFG., INC. | ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE | 04/25/1996 |
| K030504 | IDEV TECHNOLOGIES, INC. | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 | 09/16/2003 |
| K060016 | KENSEY NASH CORP. | THROMCAT THROMBECTOMY CATHETER SYSTEM | 04/25/2006 |
| K072195 | KENSEY NASH CORP. | THROMCAT THROMBECTOMY CATHETER SYSTEM | 08/23/2007 |
| K122916 | MEDRAD, INC. | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | 10/19/2012 |
| K130637 | MEDRAD, INC. | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | 04/10/2013 |
| K133023 | MEDRAD, INC. | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | 08/27/2014 |
| K161361 | Medtronic Vascular, Inc. | HawkOne Directional Atherectomy System | 10/14/2016 |
| K170191 | MEDTRONIC VASCULAR, INC. | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System | 06/16/2017 |
| K212027 | Medtronic, Inc | TurboHawk Plus Directional Atherectomy System | 08/24/2021 |
| K963925 | MICRO THERAPEUTICS, INC. | THROMBOLYTIC BRUSH CATHETER | 08/08/1997 |
| K973669 | MICRO THERAPEUTICS, INC. | THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) | 02/06/1998 |
| K982657 | MICROVENA CORP. | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 | 11/18/1998 |
| K971984 | MICROVENA CORP. | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) | 09/19/1997 |
| K954205 | MICROVENA CORP. | THE AMPLATZ THROMBECTOMY DEVICE | 08/13/1996 |
| K091509 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G2 NXT SYSTEM, MODEL PV20300 | 06/19/2009 |
| K083837 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | 01/13/2009 |
| K090325 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) | 03/11/2009 |
| K111229 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 (R) SF 1.6 SYSTEM | 06/01/2011 |
| K093918 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) | 01/21/2010 |
| K100462 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 | 05/19/2010 |
| K101334 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON | 06/11/2010 |
| K093456 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 SYSTEM | 12/01/2009 |
| K092332 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) | 09/03/2009 |
| K101221 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 | 06/02/2010 |
| K120242 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM NAVITUS L SYSTEM | 02/24/2012 |
| K110626 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM | 04/20/2011 |
| K083489 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 | 01/23/2009 |
| K082664 | PATHWAY MEDICAL TECHNOLOGIES, INC. | JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 | 10/06/2008 |
| K082186 | PATHWAY MEDICAL TECHNOLOGIES, INC. | MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM | 08/29/2008 |
| K081328 | PATHWAY MEDICAL TECHNOLOGIES, INC. | PATHWAY PV ATHERECTOMY SYSTEM | 07/17/2008 |
| K960970 | POSSIS MEDICAL, INC. | POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P | 12/03/1996 |
| K993564 | POSSIS MEDICAL, INC. | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 | 04/28/2000 |
| K033793 | REX MEDICAL | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM | 12/16/2003 |
| K120346 | REX MEDICAL | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | 06/01/2012 |
| K091029 | REX MEDICAL | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | 02/18/2010 |
| K040252 | REX MEDICAL | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | 02/26/2004 |
| K031610 | REX MEDICAL | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM | 05/27/2003 |
| K060904 | REX MEDICAL LP | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | 04/28/2006 |
| K212351 | Rex Medical, L.P. | Revolution Peripheral Atherectomy System | 12/15/2021 |
| K191419 | Rex Medical, L.P. | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire | 09/12/2019 |
| K250385 | Spectranetics | Turbo-Elite Laser Atherectomy Catheter | 03/13/2025 |
| K123632 | SPECTRANETICS CORP. | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 | 01/25/2013 |
| K094036 | SPECTRANETICS CORP. | TURBO-TANDEM SYSTEM MODEL 472-110 | 01/25/2010 |
| K140775 | SPECTRANETICS CORPORATION | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM | 07/23/2014 |
| K222837 | Spectranetics Inc. | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | 12/08/2022 |
| K170059 | Spectranetics, Inc. | Spectranetics Turbo-Elite Laser Atherectomy Catheters | 04/07/2017 |
| K162561 | SPECTRANETICS, INC. | Turbo-Power (2.0mm) Laser Atherectomy Catheters | 01/05/2017 |
| K172687 | Spectranetics, Inc. | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | 11/27/2017 |
| K180694 | Spectranetics, Inc. | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | 04/05/2018 |
| K152181 | SPECTRANETICS, INC. | Turbo-Power Laser Atherectomy Catheter | 11/12/2015 |
| K172315 | Straub Medical AG | Straub Endovascular System | 04/12/2018 |
| K172386 | Volcano AtheroMed Inc | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | 08/24/2017 |
| K181877 | Volcano AtheroMed Inc. | Phoenix 2.4mm Atherectomy Plus System | 12/17/2018 |
| K182972 | Volcano AtheroMed Inc. | Phoenix Atherectomy System | 12/20/2018 |
| K143328 | Volcano AtheroMed, Inc. | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | 12/19/2014 |
| K151145 | Volcano AtheroMed, Inc. | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | 05/26/2015 |
| K211518 | Volcano AtheroMed, Inc. | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | 06/14/2021 |
| K013473 | XTRAK MEDICAL INC. | XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL | 03/06/2002 |
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