FDA Product Code
FDA Product Code NRY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 115 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | 2026-09-14 | Traditional | PDF ↗ |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | 2026-08-28 | Traditional | PDF ↗ |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | 2026-08-13 | Special | PDF ↗ |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2026-08-12 | Special | PDF ↗ |
| K262399 | Millipede System | Perfuze, Ltd. | 2026-08-12 | Special | PDF ↗ |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | 2026-07-16 | Traditional | PDF ↗ |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. | 2026-06-10 | Traditional | PDF ↗ |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 | Traditional | PDF ↗ |
| K254276 | Lynx Aspiration Catheter System | QApel Medical, Inc. | 2026-05-07 | Traditional | PDF ↗ |
| K253590 | Millipede System | Perfuze, Ltd. | 2026-03-16 | Traditional | PDF ↗ |
| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical Ltd. | 2026-03-12 | Traditional | PDF ↗ |
| K251357 | Esperance pHLO Aspiration System | Phenox, Ltd. | 2026-01-15 | Traditional | PDF ↗ |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 2025-11-10 | Traditional | PDF ↗ |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | 2025-10-30 | Traditional | PDF ↗ |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical Ltd. | 2025-10-06 | Traditional | PDF ↗ |
| K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | 2025-09-25 | Special | PDF ↗ |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-08-29 | Special | PDF ↗ |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2025-08-22 | Special | PDF ↗ |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2025-06-03 | Traditional | PDF ↗ |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | 2025-05-28 | Traditional | PDF ↗ |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2025-05-19 | Traditional | PDF ↗ |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-04-30 | Special | PDF ↗ |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-04-28 | Special | PDF ↗ |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-02-26 | Special | PDF ↗ |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-02-24 | Traditional | PDF ↗ |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2025-02-13 | Traditional | PDF ↗ |
| K242672 | Zoom System | Imperative Care, Inc. | 2025-01-14 | Traditional | PDF ↗ |
| K243080 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-10-29 | Special | PDF ↗ |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2024-10-16 | Traditional | PDF ↗ |
| K240917 | Esperance 3+ Aspiration Catheter System | Wallaby Medical | 2024-10-01 | Traditional | PDF ↗ |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2024-09-20 | Special | PDF ↗ |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2024-07-02 | Traditional | PDF ↗ |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2024-04-23 | Special | PDF ↗ |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2024-02-29 | Traditional | PDF ↗ |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2024-01-17 | Special | PDF ↗ |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2023-10-18 | Traditional | PDF ↗ |
| K223913 | Socrates Aspiration System | Scientia Vascular, Inc. | 2023-09-20 | Traditional | PDF ↗ |
| K222786 | 072 Aspiration System | Q'Apel Medical, Inc. | 2023-08-25 | Traditional | PDF ↗ |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | Rapid Medical Ltd. | 2023-04-17 | Special | PDF ↗ |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2023-04-11 | Traditional | PDF ↗ |
| K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2023-04-10 | Special | PDF ↗ |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2023-02-17 | Traditional | PDF ↗ |
| K222808 | Penumbra System (Reperfusion Catheter RED 43) | Penumbra, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K220808 | Tigertriever 13 Revascularization Device | Rapid Medical Ltd. | 2022-07-25 | Traditional | PDF ↗ |
| K211120 | ERIC Retrieval Device | MicroVention, Inc. | 2022-03-31 | Traditional | PDF ↗ |
| K211697 | Esperance Aspiration Catheter System | Wallaby Medical | 2021-11-16 | Traditional | PDF ↗ |
| K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021-10-13 | Special | PDF ↗ |
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2021-08-16 | Traditional | PDF ↗ |
| K211338 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K211411 | Penumbra System (RED 68 Reperfusion Catheter) | Penumbra, Inc. | 2021-07-01 | Traditional | PDF ↗ |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021-06-08 | Special | PDF ↗ |
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | Penumbra, Inc. | 2021-05-20 | Traditional | PDF ↗ |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021-04-23 | Special | PDF ↗ |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Rapid Medical Ltd. | 2021-03-23 | Traditional | PDF ↗ |
| K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2020-09-02 | Special | PDF ↗ |
| K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | Penumbra, Inc. | 2020-08-31 | Special | PDF ↗ |
| K201689 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-07-21 | Special | PDF ↗ |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020-07-20 | Traditional | PDF ↗ |
| K193063 | EMBOTRAP III Revascularization Device | Neuravi, Ltd. | 2020-07-14 | Traditional | PDF ↗ |
| K191946 | Penumbra System Penumbra JET 7X | Penumbra, Inc. | 2020-02-27 | Traditional | PDF ↗ |
| K190338 | 046 Zenith Flex | Inneuroco, Inc. | 2019-08-02 | Traditional | PDF ↗ |
| K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019-07-30 | Special | PDF ↗ |
| K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2019-06-16 | Traditional | PDF ↗ |
| K190464 | Penumbra System 3D Revascularization Device | Penumbra, Inc. | 2019-04-26 | Traditional | PDF ↗ |
| K190212 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019-04-24 | Special | PDF ↗ |
| K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter | Imperative Care, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | Stryker | 2019-03-13 | Traditional | PDF ↗ |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-18 | Special | PDF ↗ |
| K182101 | Riptide Aspiration System (React 71 Catheter) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 | Traditional | PDF ↗ |
| K181354 | 074 Zenith Flex System | Inneuroco, Inc. | 2018-10-25 | Traditional | PDF ↗ |
| K182522 | Penumbra System (Modified 110 Aspiration Tubing) | Penumbra, Inc. | 2018-10-12 | Special | PDF ↗ |
| K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018-08-17 | Traditional | PDF ↗ |
| K180705 | Riptide Aspiration System React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 | Traditional | PDF ↗ |
| K180008 | Penumbra System | Penumbra, Inc. | 2018-06-20 | Traditional | PDF ↗ |
| K173200 | SOFIA Plus Aspiration Catheter | MicroVention, Inc. | 2018-06-11 | Traditional | PDF ↗ |
| K173452 | EmboTrap ll Revascularization Device | Neuravi, Ltd. | 2018-05-09 | Traditional | PDF ↗ |
| K172167 | Zenith Flex System | Inneuroco, Inc. | 2018-04-19 | Traditional | PDF ↗ |
| K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | Stryker | 2018-03-18 | Traditional | PDF ↗ |
| K172448 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-12-21 | Traditional | PDF ↗ |
| K162901 | Penumbra 3D Revascularization Device | Penumbra, Inc. | 2017-04-20 | Traditional | PDF ↗ |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mm | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-03-08 | Traditional | PDF ↗ |
| K161879 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-09-21 | Special | PDF ↗ |
| K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016-07-12 | Special | PDF ↗ |
| K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016-06-12 | Special | PDF ↗ |
| K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016-05-25 | Traditional | PDF ↗ |
| K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016-01-13 | Traditional | PDF ↗ |
| K153071 | Solitaire Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-12-23 | Special | PDF ↗ |
| K151623 | Penumbra System 110 Aspiration Tubing | Penumbra, Inc. | 2015-08-06 | Special | PDF ↗ |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | Concentric Medical, Inc. | 2015-06-12 | Traditional | PDF ↗ |
| K142458 | Penumbra System ACE | Penumbra, Inc. | 2015-05-22 | Traditional | PDF ↗ |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | Concentric Medical, Inc. | 2015-04-06 | Traditional | PDF ↗ |
| K141516 | MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-02-05 | Traditional | PDF ↗ |
| K141491 | SOLITAIRE 2 REVASCULARIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-10-22 | Traditional | PDF ↗ |
| K133317 | PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX | Penumbra, Inc. | 2014-05-13 | Traditional | PDF ↗ |
| K133464 | MODIFIED TREVO PROVUE RETRIEVER | Concentric Medical, Inc. | 2014-01-17 | Special | PDF ↗ |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER | Concentric Medical, Inc. | 2014-01-13 | Traditional | PDF ↗ |
| K123378 | SOLITAIRE 2 REVASCULARIZATION DEVICE | Micro Therapeutics Dba Ev3 Neurovascular | 2012-11-30 | Special | PDF ↗ |
| K122478 | MODIFIED TREVO RETRIEVER | Concentric Medical, Inc. | 2012-10-31 | Traditional | PDF ↗ |
| K120961 | TREVO RETRIEVER | Concentric Medical, Inc. | 2012-08-03 | Traditional | PDF ↗ |
Product code NRY · Class II · Cardiovascular. Data: openFDA.