NRY — Catheter, Thrombus Retriever Class II
Classification Details
- Product Code
- NRY
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253062 | rapid medical | Tigertriever 25 Revascularization Device | March 12, 2026 |
| K251357 | phenox | Esperance pHLO Aspiration System | January 15, 2026 |
| K251006 | vesalio | NeVasc Aspiration System | November 10, 2025 |
| K252046 | imperative care | Zoom System (Zoom 4S Catheter) | October 30, 2025 |
| K251603 | rapid medical | Tigertriever 17 Ultra Revascularization Device | October 6, 2025 |
| K251789 | neuravi limited | EMBOTRAP III Revascularization Device | September 25, 2025 |
| K252392 | perfuze | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | August 29, 2025 |
| K251828 | cerenovus | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | August 22, 2025 |
| K243948 | balt usa | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | June 3, 2025 |
| K243047 | imperative care | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | May 28, 2025 |
| K243601 | route 92 medical | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | May 19, 2025 |
| K251015 | alembic | APRO 45 Catheter and Alembic Aspiration Tubing | April 30, 2025 |
| K250958 | alembic | APRO 55 Swift Catheter and Alembic Aspiration Tubing | April 28, 2025 |
| K250012 | perfuze | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | February 26, 2025 |
| K243287 | alembic | APRO 70 Swift Catheter and Alembic Aspiration Tubing | February 24, 2025 |
| K242104 | penumbra | Penumbra System (Reperfusion Catheter RED 72) | February 13, 2025 |
| K242672 | imperative care | Zoom System | January 14, 2025 |
| K243080 | micro therapeutics, inc. d/b/a ev3 neurovascular | Riptide Aspiration System | October 29, 2024 |
| K241221 | cerenovus | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovu | October 16, 2024 |
| K240917 | wallaby medical | Esperance 3+ Aspiration Catheter System | October 1, 2024 |