Product code NRY
- Device name
- Catheter, Thrombus Retriever
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular SciTech Limited | 2026-05-20 |
| K254276 | Lynx Aspiration Catheter System | Q’Apel Medical, Inc. | 2026-05-07 |
| K253590 | Millipede System | Perfuze, Ltd. | 2026-03-16 |
| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical , Ltd. | 2026-03-12 |
| K251357 | Esperance pHLO Aspiration System | Phenox, Ltd. | 2026-01-15 |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 2025-11-10 |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | 2025-10-30 |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical , Ltd. | 2025-10-06 |
| K251789 | EMBOTRAP III Revascularization Device | Neuravi Limited | 2025-09-25 |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-08-29 |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2025-08-22 |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2025-06-03 |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | 2025-05-28 |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2025-05-19 |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-04-30 |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-04-28 |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-02-26 |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2025-02-24 |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. | 2025-02-13 |
| K242672 | Zoom System | Imperative Care, Inc. | 2025-01-14 |
| K243080 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-10-29 |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2024-10-16 |
| K240917 | Esperance 3+ Aspiration Catheter System | Wallaby Medical | 2024-10-01 |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2024-09-20 |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2024-07-02 |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | 2024-04-23 |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2024-02-29 |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2024-01-17 |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2023-10-18 |
| K223913 | Socrates Aspiration System | Scientia Vascular, Inc. | 2023-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886704088141 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704088097 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704088103 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704088110 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704086512 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704085355 | CEREGLIDE | Cerenovus, Inc. | 2023-07-07 |
| 10886704085386 | CEREGLIDE | Cerenovus, Inc. | 2023-07-07 |
| 07613327519358 | AXS VECTA 46 | Stryker Corporation | 2021-12-17 |
| 07613327519365 | AXS VECTA 46 | Stryker Corporation | 2021-12-17 |
| 07613327519389 | AXS VECTA 46 | Stryker Corporation | 2021-12-17 |
| 07613327299946 | Trevo NXT | Stryker Corporation | 2020-04-20 |
| 00763000270209 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270162 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270346 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270353 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270360 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270384 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270179 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270216 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270230 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270247 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270292 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270308 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270315 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270322 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270339 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 07613327417210 | AXS Catalyst 7 | Stryker Corporation | 2019-05-13 |
| 07613327011999 | AXS Catalyst 5 | Stryker Corporation | 2016-09-21 |
| 07613327012033 | AXS Catalyst 6 | Stryker Corporation | 2016-09-21 |
| 07613327012019 | AXS Catalyst 5 | Stryker Corporation | 2016-09-21 |