Route 92 Medical, Inc.
Route 92 Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2025, with 5 FDA device recalls on record.
Top product codes for Route 92 Medical, Inc.
FDA recalls by Route 92 Medical, Inc.
- Z-1613-2024 — Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Z-1614-2024 — Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
- Z-1610-2024 — Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
- Z-1612-2024 — Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Z-1611-2024 — Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Route 92 Medical, Inc.
- K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- K240529 — 8F Modified Sheath System
- K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
- K231583 — Route 92 Medical Full Length 054 Access System
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
- K222743 — Route 92 Medical Full Length 070 Access System
- K210635 — Route 92 Medical Full Length 088 Access System
- K203043 — Route 92 Medical 070 Access System
- K200121 — Route 92 Medical 088 Access System, 110 cm
- K191717 — Route 92 Medical Sheath System
- K190431 — Route 92 Medical Delivery Catheter
- K182512 — Route 92 Medical Delivery Catheter
- K180201 — Route 92 Medical Access System
Data sourced from openFDA. This site is unofficial and independent of the FDA.