ClearanceBrief
Panels › Cardiovascular › Product code NRY · Class 2

Catheter, Thrombus Retriever

Regulation 870.1250

15510(k)s in 12 months (117 all time)
2recalls in 12 months (27 all time)
23recalls that name a 510(k)
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Top companies in NRY

Decided510(k)Device and applicantCode
Aug 16, 2021K211654Penumbra System (Reperfusion Catheter RED 72)
Penumbra, Inc.
NRY
Jul 30, 2021K211338EMBOTRAP III Revascularization Device
Neuravi, Ltd., IE
NRY
Jul 1, 2021K211411Penumbra System (RED 68 Reperfusion Catheter)
Penumbra, Inc.
NRY
Jun 8, 2021K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
Imperative Care, Inc.
NRY
May 20, 2021K203440Penumbra System (Reperfusion Catheter RED 62)
Penumbra, Inc.
NRY
Apr 23, 2021K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Imperative Care, Inc.
NRY
Mar 23, 2021K203592Tigertriever and Tigertriever 17 Revascularization Devce
Rapid Medical Ltd., IL
NRY
Sep 2, 2020K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Imperative Care, Inc.
NRY
Aug 31, 2020K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
Penumbra, Inc.
NRY
Jul 21, 2020K201689Riptide Aspiration System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Jul 20, 2020K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
Codman & Shurtleff, Inc.
NRY
Jul 14, 2020K193063EMBOTRAP III Revascularization Device
Neuravi, Ltd., IE
NRY
Feb 27, 2020K191946Penumbra System Penumbra JET 7X
Penumbra, Inc.
NRY
Aug 2, 2019K190338046 Zenith Flex
Inneuroco, Inc.
NRY
Jul 30, 2019K191768AXS Vecta Aspiration System
Stryker Neurovascular
NRY
Jun 16, 2019K190010Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.
NRY
Apr 26, 2019K190464Penumbra System 3D Revascularization Device
Penumbra, Inc.
NRY
Apr 24, 2019K190212AXS Vecta Aspiration System
Stryker Neurovascular
NRY
Apr 17, 2019K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Cathete
Imperative Care, Inc.
NRY
Mar 13, 2019K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
Stryker
NRY
Dec 18, 2018K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Nov 14, 2018K182101Riptide Aspiration System (React 71 Catheter)
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Oct 25, 2018K181354074 Zenith Flex System
Inneuroco, Inc.
NRY
Oct 12, 2018K182522Penumbra System (Modified 110 Aspiration Tubing)
Penumbra, Inc.
NRY
Aug 17, 2018K173761Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.
NRY
Jul 4, 2018K180705Riptide Aspiration System React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Jun 20, 2018K180008Penumbra System
Penumbra, Inc.
NRY
Jun 11, 2018K173200SOFIA Plus Aspiration Catheter
MicroVention, Inc.
NRY
May 9, 2018K173452EmboTrap ll Revascularization Device
Neuravi, Ltd., IE
NRY
Apr 19, 2018K172167Zenith Flex System
Inneuroco, Inc.
NRY
Mar 18, 2018K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Ac
Stryker
NRY
Dec 21, 2017K172448Riptide Aspiration System
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Apr 20, 2017K162901Penumbra 3D Revascularization Device
Penumbra, Inc.
NRY
Mar 8, 2017K160641Solitaire Platinum Revascularization Device, 6x40 mm
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Sep 21, 2016K161879Solitaire Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Jul 12, 2016K161640Penumbra System ACE 68 Reperfusion Catheter
Penumbra, Inc.
NRY
Jun 12, 2016K161064Penumbra System ACE 68 Reperfusion Catheter
Penumbra, Inc.
NRY
May 25, 2016K160449Penumbra System, Penumbra Pump MAX
Penumbra, Inc.
NRY
Jan 13, 2016K152541Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
Penumbra, Inc.
NRY
Dec 23, 2015K153071Solitaire Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Aug 6, 2015K151623Penumbra System 110 Aspiration Tubing
Penumbra, Inc.
NRY
Jun 12, 2015K150616Trevo XP ProVue Retriever (4x30mm)
Concentric Medical, Inc.
NRY
May 22, 2015K142458Penumbra System ACE
Penumbra, Inc.
NRY
Apr 6, 2015K143077Trevo XP ProVue Retriever (6X25mm)
Concentric Medical, Inc.
NRY
Feb 5, 2015K141516MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
Oct 22, 2014K141491SOLITAIRE 2 REVASCULARIZATION DEVICE
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
NRY
May 13, 2014K133317PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
Penumbra, Inc.
NRY
Jan 17, 2014K133464MODIFIED TREVO PROVUE RETRIEVER
Concentric Medical, Inc.
NRY
Jan 13, 2014K132641MODIFIED TREVO PROVUE RETRIEVER
Concentric Medical, Inc.
NRY
Nov 30, 2012K123378SOLITAIRE 2 REVASCULARIZATION DEVICE
Micro Therapeutics Dba Ev3 Neurovascular
NRY

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