San Mateo, CA, US · 12 510(k) clearances · 5 recalls (5 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | Class II | Cardiovascular | 8 | 2026-09-16 |
| NRY | Catheter, Thrombus Retriever | Class II | Cardiovascular | 3 | 2025-05-19 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | 1 | 2020-01-13 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-03-08 | Class I | Ongoing | Z-1614-2024 | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i… | — | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-03-08 | Class I | Ongoing | Z-1613-2024 | Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de… | — | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-03-08 | Class I | Ongoing | Z-1612-2024 | Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int… | — | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-03-08 | Class I | Ongoing | Z-1611-2024 | Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio… | — | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-03-08 | Class I | Ongoing | Z-1610-2024 | Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev… | — | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-16 | K260220 | Route 92 Medical Full Length 046 Access System | QJP | Class II | Cardiovascular |
| 2025-05-19 | K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2024-10-02 | K240529 | 8F Modified Sheath System | QJP | Class II | Cardiovascular |
| 2024-04-23 | K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2023-08-15 | K231583 | Route 92 Medical Full Length 054 Access System | QJP | Class II | Cardiovascular |
| 2023-04-11 | K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | NRY | Class II | Cardiovascular |
| 2022-10-04 | K222743 | Route 92 Medical Full Length 070 Access System | QJP | Class II | Cardiovascular |
| 2021-07-27 | K210635 | Route 92 Medical Full Length 088 Access System | QJP | Class II | Cardiovascular |
| 2020-11-11 | K203043 | Route 92 Medical 070 Access System | QJP | Class II | Cardiovascular |
| 2020-08-14 | K201518 | Route 92 Medical 088 Access System | QJP | Class II | Cardiovascular |
| 2020-04-18 | K200121 | Route 92 Medical 088 Access System, 110 cm | QJP | Class II | Cardiovascular |
| 2020-01-13 | K191717 | Route 92 Medical Sheath System | DQY | Class II | Cardiovascular |