FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K220780 |
2MG, Inc |
ROVO Mechanical Thrombectomy Device |
03/31/2023 |
K182835 |
880 Medical, LLC |
WOLF Thrombectomy Device |
03/27/2019 |
K211798 |
Argon Medical Devices, Inc. |
Cleaner Plus Thrombectomy System |
02/24/2022 |
K011056 |
ARROW INTL., INC. |
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD |
10/24/2001 |
K083370 |
ARTEGRAFT, INC. |
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 |
12/12/2008 |
K151313 |
BOSTON SCIENTIFIC CORPORATION |
ZelanteDVT Thrombectomy Set |
09/21/2015 |
K202218 |
Boston Scientific Corporation |
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device |
10/02/2020 |
K220270 |
C.R. Bard, Inc. |
Aspirex Thrombectomy System |
06/21/2022 |
K230356 |
C.R. Bard, Inc. |
AspirexÖ Thrombectomy System |
03/31/2023 |
K132281 |
Codman & Shurtleff, Inc. |
ReVive PV (Peripheral Vasculature) Thrombectomy Device |
08/30/2013 |
K223897 |
Contego Medical Inc. |
Excipio LV Thrombectomy Device |
02/17/2023 |
K221204 |
Contego Medical Inc. |
Excipio SV Thrombectomy Device |
06/23/2022 |
K230030 |
Contego Medical, Inc. |
Excipio SV Aspiration Catheter and Tubing |
05/30/2023 |
K221391 |
DeVoro Medical, Inc |
WOLF ThrombectomyÖ SmartClaw Catheter |
11/10/2022 |
K210911 |
DeVoro Medical, Inc. |
WOLF Thrombectomy System, 14F |
10/19/2021 |
K210530 |
DeVoro Medical, Inc. |
WOLF Thrombectomy System, 6F |
08/27/2021 |
K200101 |
DeVoro Medical, Inc. |
WOLF Thrombectomy V System |
04/27/2020 |
K223891 |
Endovascular Engineering |
Cobra Catheter System |
02/15/2023 |
K092623 |
GENESIS MEDICAL INTERVENTIONAL, INC. |
F.A.S.T. SYSTEM SED AND CXD |
10/30/2009 |
K040010 |
GENESIS MEDICAL INTERVENTIONAL, INC. |
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS |
07/19/2004 |
K230743 |
ICHOR |
ICHOR 14F Embolectomy System |
09/05/2023 |
K182167 |
ICHOR Vascular, Inc. |
The ICHOR Panacea Vascular Embolectomy Catheter System |
12/21/2018 |
K041374 |
IDEV TECHNOLOGIES, INC. |
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 |
03/02/2005 |
K223436 |
Inari Medical |
Artix AX |
03/02/2023 |
K223000 |
Inari Medical |
Artix BG |
01/11/2023 |
K230912 |
Inari Medical |
Artix BG |
05/02/2023 |
K220600 |
Inari Medical |
Artix Thrombectomy Device |
03/25/2022 |
K193462 |
Inari Medical |
ClotTriever Thrombectomy System |
09/09/2020 |
K192036 |
Inari Medical |
ClotTriever Thrombectomy System |
08/29/2019 |
K182531 |
Inari Medical |
ClotTriever Thrombectomy System |
10/10/2018 |
K173470 |
Inari Medical |
ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath |
12/04/2017 |
K192332 |
Inari Medical |
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath |
09/20/2019 |
K201541 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
12/04/2020 |
K202345 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
12/18/2020 |
K181694 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
07/27/2018 |
K182233 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
10/15/2018 |
K183198 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
12/17/2018 |
K191368 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
06/17/2019 |
K191710 |
Inari Medical |
FlowTriever Retrieval/Aspiration System |
09/05/2019 |
K173672 |
Inari Medical |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter |
02/05/2018 |
K162970 |
Inari Medical |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator |
11/22/2016 |
K220887 |
Inari Medical |
Mini-ClotTriever Thrombectomy System |
08/04/2022 |
K152097 |
INARI MEDICAL |
Retraction Aspirator |
08/25/2015 |
K210195 |
Inari Medical |
Triever Catheters |
02/24/2021 |
K223419 |
Inari Medical |
Triever16 Curve |
03/23/2023 |
K213402 |
Inari Medical |
Triever24, Triever20 |
05/23/2022 |
K223613 |
Inari Medical, Inc |
InThrill Thrombectomy System |
03/17/2023 |
K230494 |
Inari Medical, Inc. |
ClotTriever BOLD Catheter |
04/18/2023 |
K221531 |
Inari Medical, Inc. |
ClotTriever Thrombectomy System |
02/06/2023 |
K210689 |
Inari Medical, Inc. |
ClotTriever Thrombectomy System |
05/12/2021 |
K212632 |
Inari Medical, Inc. |
ClotTriever Thrombectomy System |
10/18/2021 |
K180329 |
Inari Medical, Inc. |
ClotTriever Thrombectomy System |
04/09/2018 |
K163549 |
Inari Medical, Inc. |
ClotTriever Thrombectomy System |
02/16/2017 |
K223210 |
Inari Medical, Inc. |
ClotTriever XL Catheter |
04/27/2023 |
K181325 |
Inari Medical, Inc. |
FlowTriever Retrieval/Aspiration System |
06/17/2018 |
K180466 |
Inari Medical, Inc. |
FlowTriever Retrieval/Aspiration System |
05/17/2018 |
K211013 |
Inari Medical, Inc. |
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 |
04/30/2021 |
K143563 |
Inari Medical, Inc. |
Infusion Aspiration Catheter System |
02/03/2015 |
K220415 |
Inari Medical, Inc. |
Protrieve Sheath |
07/12/2022 |
K230331 |
Inari Medical, Inc. |
Protrieve Sheath |
03/07/2023 |
K223609 |
Inari Medical, Inc. |
RevCoreÖ Thrombectomy Catheter. |
03/14/2023 |
K231848 |
Inari Medical, Inc. |
Triever20 Curve (21-201) |
07/21/2023 |
K203333 |
Inari Medical, Inc. |
Triever20 Curve Catheter |
12/10/2020 |
K223929 |
Innova Vascular, Inc. |
LagunaÖ Clot Retriever System and MalibuÖ Aspiration Catheter System (Laguna Thrombectomy System) |
06/01/2023 |
K210190 |
Irani Medical, Inc. |
ClotTriever Thrombectomy System |
02/23/2021 |
K180722 |
KP Medcure, Inc. |
CAPERE Thrombectomy System |
06/11/2018 |
K080901 |
LUMEN BIOMEDICAL, INC. |
LBI EMBOLECTOMY SYSTEM |
10/02/2008 |
K130381 |
MEDRAD, INC. |
ANGIOJET ULTRA POWER PULSE KIT |
07/29/2013 |
K991093 |
METAMORPHIC SURGICAL DEVICES, LLC. |
MSD EMBOLECTOMY BASKET |
12/21/2000 |
K090932 |
NEXGEN MEDICAL SYSTEMS, INC. |
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 |
09/24/2009 |
K192981 |
Penumbra, Inc |
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 |
05/28/2020 |
K161523 |
Penumbra, Inc. |
INDIGO Aspiration System |
07/01/2016 |
K192833 |
Penumbra, Inc. |
Indigo Aspiration System |
12/20/2019 |
K202821 |
Penumbra, Inc. |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
11/18/2020 |
K193595 |
Penumbra, Inc. |
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 |
08/19/2020 |
K210323 |
Penumbra, Inc. |
Indigo Aspiration System - Lightning Aspiration Tubing |
02/26/2021 |
K222358 |
Penumbra, Inc. |
Indigo Aspiration System - Lightning Flash |
12/20/2022 |
K180939 |
Penumbra, Inc. |
Indigo Aspiration System - Modified 110 Aspiration Tubing |
05/03/2018 |
K180105 |
Penumbra, Inc. |
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister |
03/08/2018 |
K180412 |
Penumbra, Inc. |
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister |
05/15/2018 |
K220683 |
Penumbra, Inc. |
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) |
10/04/2022 |
K200771 |
Penumbra, Inc. |
Indigo Aspiration System Lightning Aspiration Tubing |
04/22/2020 |
K193244 |
Penumbra, Inc. |
Indigo Aspiration System û Lightning Aspiration Tubing |
03/13/2020 |
K210083 |
Penumbra, Inc. |
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 |
02/09/2021 |
K223186 |
Penumbra, Inc. |
Indigo« Aspiration System û Lightning Bolt Aspiration Tubing |
02/13/2023 |
K161506 |
Penumbra, Inc. |
Penumbra Aspiration System |
09/26/2016 |
K121917 |
PENUMBRA, INC. |
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM |
09/19/2012 |
K160533 |
PENUMBRA, INC. |
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) |
05/24/2016 |
K142870 |
PENUMBRA, INC. |
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] |
05/26/2015 |
K133629 |
POSSIS MEDICAL, INC. |
ANGIOJET ULTRA AVX THROMBECTOMY SET |
02/14/2014 |
K141617 |
REX MEDICAL, L.P. |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
11/14/2014 |
K220501 |
Surmodics Inc. |
Pounce Thrombectomy System |
03/23/2022 |
K231022 |
Surmodics Inc. |
PounceÖ Thrombectomy System |
06/12/2023 |
K211492 |
Surmodics, Inc. |
Pounce Thrombectomy System |
07/30/2021 |
K192814 |
Surmodics, Inc. |
Pounce Thrombus Retrieval System |
09/21/2020 |
K214114 |
Truvic Medical Inc. |
Prodigy Thrombectomy System |
04/06/2022 |
K223216 |
Truvic Medical Inc. |
Symphony Thrombectomy System |
02/23/2023 |
K172716 |
V2K Medical Inc. |
V2K Rinspiration System |
01/26/2018 |
K203476 |
Vascular Medcure, INC. |
CAPERE Thrombectomy System |
12/22/2020 |
K183179 |
Vascular Medcure, Inc. |
CAPERE Thrombectomy System |
02/25/2019 |
K192935 |
Vascular Medcure, Inc. |
CAPERE Thrombectomy System |
11/15/2019 |
K200314 |
Vascular Medcure, Inc. |
Capere Thrombectomy System |
03/04/2020 |
K201216 |
Vascular Medcure, Inc. |
CAPERE Thrombectomy System |
07/08/2020 |
K201085 |
Vesalio |
NeVa PV Thrombectomy Device |
01/15/2021 |
K201705 |
Vetex Medical, Ltd. |
ReVene Thrombectomy Catheter |
12/22/2020 |
K021641 |
XTRAK MEDICAL INC. |
XTD THROMBECTOMY CATHETER, XX CM |
07/26/2002 |