FDA 510(k) Applications for Medical Device Product Code "QEZ"

FDA 510(k) Number Applicant Device Name Decision Date
K213388 AngioDynamics, Inc. AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System 04/04/2022
K211081 AngioDynamics, Inc. AlphaVac Multipurpose Mechanical Aspiration (MMA) System 06/04/2021
K051880 BOSTON SCIENTIFIC CORP. RIO ASPIRATION CATHETER 01/04/2006
K091703 CONCENTRIC MEDICAL, INC. HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 10/14/2009
K200871 Control Medical Technology Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator 05/04/2020
K113757 CONTROL MEDICAL TECHNOLOGY, LLC ASPIRE MAX ASPIRATION CATHETER 02/22/2012
K131998 CONTROL MEDICAL TECHNOLOGY, LLC ASPIRE RX-LP6 ASPIRATION CATHETER 11/26/2013
K073627 COOK, INC. FLEXOR EVAC ASPIRATION CATHETER 03/04/2008
K990771 CORDIS CORP. 6F HYDROLYSER THROMBECTOMY CATHETER 06/25/1999
K983534 CORDIS CORP. 7F HYDROLYSER THROMBECTOMY CATHETER 02/26/1999
K990805 CORDIS CORP. MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER 03/15/1999
K071826 FOX HOLLOW TECHNOLOGIES THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 11/09/2007
K050276 INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. DIVER C.E. CATHETER 03/07/2005
K051917 INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. DIVER C.E. CATHETER 08/08/2005
K213166 Kaneka Medical America LLC Thrombuster II Aspiration Catheter 10/26/2021
K101839 KANEKA PHARMA AMERICA LLC KANEKA PHARMA AMERICA XPRESS-WAY RX 10/22/2010
K121301 KANEKA PHARMA AMERICA LLC XPRESSWAY RX CATHETER (6F LD-VERISON) 07/30/2012
K060092 KENSEY NASH CORP. QUICKCAT EXTRACTION CATHETER 03/09/2006
K073519 KENSEY NASH CORP. QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 03/28/2008
K050130 KERBEROS PROXIMAL SOLUTIONS, INC. KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM 05/13/2005
K062275 KERBEROS PROXIMAL SOLUTIONS, INC. RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 09/20/2006
K053372 LUMEN BIOMEDICAL, INC. LBI CATHETER SYSTEM 06/30/2006
K071529 LUMEN BIOMEDICAL, INC. XTRACT CATHETER SYSTEM 08/10/2007
K101406 MEDRAD INTERVENTIONAL/POSSIS ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 06/16/2010
K101354 MEDRAD INTERVENTIONAL/POSSIS FETCH 2 ASPIRATION CATHETER MODEL 109400-001 01/21/2011
K113363 MEDRAD, INC. ANGIOJET SOLENT DISTA THROMBECTOMY SET 06/06/2012
K111182 MEDRAD, INC. ANGIOJET SOLENT OMNI THROMBECTOMY SET 05/24/2011
K113428 MEDRAD, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET 12/02/2011
K130536 MEDTRONIC INC. EXPORT ADVANCE ASPIRATION CATHETER 07/16/2013
K120808 MEDTRONIC INC. EXPORT XT CATHETER, EXPORT AP CATHETER 06/07/2012
K040869 MEDTRONIC VASCULAR EXPORT CATHETER 06/01/2004
K061958 MEDTRONIC VASCULAR MEDTRONIC EXPORT XT CATHETER 09/05/2006
K050139 MEDTRONIC VASCULAR MODIFICATION TO: EXPORT CATHETER 03/22/2005
K190619 Meril Life Sciences Private Limited Aspiron(TM) Aspiration Catheter 04/29/2019
K212199 Merit Medical Systems, Inc. ASAP Aspiration Catheter, ASAPLP Aspiration Catheter 11/03/2021
K132155 MERIT MEDICAL SYSTEMS, INC. Merit ASAPLP Aspiration Catheter 11/07/2013
K100569 MERIT MEDICAL SYSTEMS, INC. MERIT EMBOLECTOMY CATHETER MODEL ASAP100 03/11/2011
K110315 NEXGEN MEDICAL SYSTEMS, INC. NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE 10/20/2011
K091593 POSSIS MEDICAL, INC. ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS 06/22/2009
K050794 POSSIS MEDICAL, INC. ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER 04/28/2005
K073441 POSSIS MEDICAL, INC. ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 01/24/2008
K082382 POSSIS MEDICAL, INC. ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 12/12/2008
K090253 POSSIS MEDICAL, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 04/08/2009
K072269 POSSIS MEDICAL, INC. ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 09/08/2007
K080806 POSSIS MEDICAL, INC. ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 04/04/2008
K071342 POSSIS MEDICAL, INC. ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 07/31/2007
K072769 POSSIS MEDICAL, INC. ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS 11/14/2007
K042874 POSSIS MEDICAL, INC. ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) 11/05/2004
K052256 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR 120 CATHETER 11/10/2005
K040013 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT 05/18/2004
K071336 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 08/24/2007
K071514 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 07/31/2007
K061951 POSSIS MEDICAL, INC. ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 11/22/2006
K062172 POSSIS MEDICAL, INC. FETCH ASPIRATION CATHETER 09/20/2006
K070363 POSSIS MEDICAL, INC. FETCH ASPIRATION CATHETER 05/11/2007
K081989 POSSIS MEDICAL, INC. MODIFICATION TO FETCH ASPIRATION CATHETER 09/26/2008
K972610 POSSIS MEDICAL, INC. POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C 04/11/2000
K112382 Terumo Medical Corporation TERUMO ASPRIATION CATHETER 12/14/2011
K173266 Vascular Solutions Inc. Octane aspiration system 12/01/2017
K042937 VASCULAR SOLUTIONS, INC. MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER 01/31/2005
K182232 Vascular Solutions, Inc. Octane Mechanical Thrombectomy System 09/11/2018
K070403 VASCULAR SOLUTIONS, INC. PRONTO .035 EXTRACTION CATHETER 06/13/2007
K072810 VASCULAR SOLUTIONS, INC. PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 12/19/2007
K063371 VASCULAR SOLUTIONS, INC. PRONTO V3 EXTRACTION CATHETER, MODEL 5003 12/14/2006
K083784 VASCULAR SOLUTIONS, INC. PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, 03/30/2009
K103405 VASCULAR SOLUTIONS, INC. PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH 12/22/2010
K071727 VASCULAR SOLUTIONS, INC. QXT EXTRACTION CATHETER 09/28/2007
K032763 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER 12/19/2003
K051193 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER 08/08/2005
K052232 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER 09/28/2005
K112571 VASCULAR SOLUTIONS, INC. XL EXTRACTION CATHETER 10/06/2011
K193197 Volcano AtheroMed Inc. QuickClear Mechanical Thrombectomy System 04/20/2020
K123482 VOLCANO CORPORATION REFLOW ASPIRATION CATHETER 04/29/2013
K120508 WALK VASCULAR LLC CLEARLUMEN THROMBECTOMY SYSTEM 11/07/2012
K163051 Walk Vascular, LLC ClearLumen II Peripheral Thrombectomy System 02/21/2017
K172000 Walk Vascular, LLC ClearLumen II Peripheral Thrombectomy System 10/24/2017
K161786 Walk Vascular, LLC ClearLumen II Thrombectomy System 10/18/2016
K140296 WALK VASCULAR, LLC CLEARLUMEN THROMBECTOMY SYSTEM 12/02/2014
K183403 Walk Vascular, LLC JETi 88 Peripheral Thrombectomy System 04/17/2019
K201998 Walk Vascular, LLC JETi AIO Peripheral Thrombectomy System 11/17/2020
K213565 Walk Vascular, LLC JETi AIO Peripheral Thrombectomy System 02/01/2022
K192439 Walk Vascular, LLC JETi Peripheral Thrombectomy System 12/09/2019


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact