NRY — Catheter, Thrombus Retriever Class II
FDA product code NRY covers "Catheter, Thrombus Retriever", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261089 | maduro medical | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspi | September 14, 2026 |
| K260617 | rapid medical | Tigertriever 13 Ultra Revascularization Device | August 28, 2026 |
| K262398 | cerenovus | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | August 13, 2026 |
| K262399 | perfuze | Millipede System | August 12, 2026 |
| K262391 | alembic | APRO 35 Swift Catheter and Alembic Aspiration Tubing | August 12, 2026 |
| K260002 | scientia vascular | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | July 16, 2026 |
| K250690 | penumbra | Penumbra System (Thunderbolt Aspiration Tubing) | June 10, 2026 |
| K252707 | suzhou zenith vascular scitech limited | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | May 20, 2026 |
| K254276 | qapel medical | Lynx Aspiration Catheter System | May 7, 2026 |
| K253590 | perfuze | Millipede System | March 16, 2026 |
| 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 |