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

DateFirm and productCodeLinked 510(k)
Sep 29, 2026Penumbra Inc.
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Pr
Open, Classified
NRYK203440
K250690
Jul 21, 2026Penumbra, Inc.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Open, Classified
NRYK211411
Apr 7, 2025Qapel Medical Inc.
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubi
Open, Classified
NRYK222786
Feb 26, 2025Scientia Vascular, Inc.
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute isch
Open, Classified
NRYK223913
Sep 17, 2024MICROVENTION INC.
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vascul
Open, Classified
NRYK211120
May 28, 2024Stryker Neurovascular
Trevo ProVue, Catalog: 90184
Open, Classified
NRYK133464
Apr 24, 2024ROUTE 92 MEDICAL INC
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Open, Classified
NRYK223530
Sep 29, 2021IMPERATIVE CARE INC
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Completed
NRYK183043
K202182 +1
Jan 18, 2021Penumbra Inc.
Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra
Terminated
NRYK190010
K191946 +1
Jan 18, 2021Penumbra Inc.
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of t
Terminated
NRYK190010
K191946 +1
Jan 18, 2021Penumbra Inc.
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the P
Terminated
NRYK190010
K191946 +1
Jan 18, 2021Penumbra Inc.
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers as
Terminated
NRYK190010
K191946 +1
Apr 10, 2019Stryker Neurovascular
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont,
Terminated
NRYK181354
Apr 10, 2019Stryker Neurovascular
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont,
Terminated
NRYK172167
May 16, 2018Micro Therapeutics Inc, Dba Ev3 Neurovascular
MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 30001
Terminated
NRYK141516
Dec 5, 2017Stryker Neurovascular
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
Terminated
NRYK113260
K113778 +3
Dec 5, 2017Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060
Terminated
NRYK113260
K113778 +3
Dec 5, 2017Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M
Terminated
NRYK113260
K113778 +3
Nov 28, 2017Stryker Neurovascular
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Terminated
NRYK113260
K132641
Jun 26, 2017Stryker Neurovascular
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150
Terminated
NRYNone listed
Jun 26, 2017Stryker Neurovascular
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
Terminated
NRYNone listed
Jun 26, 2017Stryker Neurovascular
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Terminated
NRYNone listed
Jun 26, 2017Stryker Neurovascular
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
Terminated
NRYNone listed
Jun 22, 2017Penumbra Inc.
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the inte
Terminated
NRYK162901
Dec 8, 2014Concentric Medical Inc
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing i
Terminated
NRYK120961
Sep 8, 2014Concentric Medical Inc
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of fo
Terminated
NRYK082034
Nov 24, 2010Penumbra Inc.
Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
Terminated
NRYK072718

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