Company ยท US
Route 92 Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K263266 | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc. | NRY |
| Sep 16, 2026 | K260220 | Route 92 Medical Full Length 046 Access System Route 92 Medical, Inc. | QJP |
| May 19, 2025 | K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc. | NRY |
| Oct 2, 2024 | K240529 | 8F Modified Sheath System Route 92 Medical, Inc. | QJP |
| Apr 23, 2024 | K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc. | NRY |
| Aug 15, 2023 | K231583 | Route 92 Medical Full Length 054 Access System Route 92 Medical, Inc. | QJP |
| Apr 11, 2023 | K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc. | NRY |
| Oct 4, 2022 | K222743 | Route 92 Medical Full Length 070 Access System Route 92 Medical, Inc. | QJP |
| Jul 27, 2021 | K210635 | Route 92 Medical Full Length 088 Access System Route 92 Medical, Inc. | QJP |
| Nov 11, 2020 | K203043 | Route 92 Medical 070 Access System Route 92 Medical, Inc. | QJP |
| Aug 14, 2020 | K201518 | Route 92 Medical 088 Access System Route 92 Medical | QJP |
| Apr 18, 2020 | K200121 | Route 92 Medical 088 Access System, 110 cm Route 92 Medical, Inc. | QJP |
| Jan 13, 2020 | K191717 | Route 92 Medical Sheath System Route 92 Medical, Inc. | DQY |
| Mar 21, 2019 | K190431 | Route 92 Medical Delivery Catheter Route 92 Medical, Inc. | DQY |
| Dec 10, 2018 | K182512 | Route 92 Medical Delivery Catheter Route 92 Medical, Inc. | DQY |
| May 23, 2018 | K180201 | Route 92 Medical Access System Route 92 Medical, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | ROUTE 92 MEDICAL INC 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. Open, Classified |
DQY | None listed |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature. Open, Classified |
DQY | K190431 |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature. Open, Classified |
QJP | K203043 |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature. Open, Classified |
NRY | K223530 |
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature. Open, Classified |
QJP | K222743 |