510(k) K233329
- Device
- Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
- Applicant
- Route 92 Medical, Inc.
- 510(k) number
- K233329
- Product code
- NRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-23
- Date received
- 2023-09-29
- Regulation
- 870.1250
- Classification name
- Catheter, Thrombus Retriever
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kirsten Valley
- Address
- 155 Bovet Rd. Suite 100 San Mateo CA US 94402 94402
FDA Registration Numbers#
- 3014644549
- 3005168196
- 3008853977
- 3010034260
- 3030088112
- 1721676
- 3015615738
- 3014211783
- 3022392708
- 3008837339
- 3008264254
- 3021009035
- 3027319104
- 2183828
- 9616664
- 3020954126
- 3009337401
- 3007007790
- 3006451981
- 3016591327
- 3008824097
- 3039020025
- 3014590707
- 3014590708
- 3012543881
- 3019807891
- 3007628272
- 3012931345
- 3013656790
- 3016678045
- 2183744
- 3003144120
- 3012497308
- 3015701715
- 1048735
- 2030624
- 3009380063
- 3009546466
- 3031288142
- 3014162263
- 2029214
- 3017168767
- 3015531723
- 1721504
- 3013556777
- 3009957947
- 3002807314
- 3008881809
- 3010079067
- 3015453963
- 3008114965
- 1220477
- 3011370111
- 3013758550
- 2011171
- 3021520400
- 2024311
- 3014498720
- 3015550451
- 3016522967
- 3016540856
Source Documents#
Other 510(k) Records For Product Code NRY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | 2026-09-14 |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | 2026-08-28 |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | 2026-08-13 |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC | 2026-08-12 |
| K262399 | Millipede System | Perfuze, Ltd. | 2026-08-12 |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | 2026-07-16 |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. | 2026-06-10 |
| 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 |