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Route 92 Medical, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories3
Latest FDA decision2025-05-19
TypeNumberDevice NameCodeDateActions
510(k) K243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY2025-05-19 View
510(k) K240529 8F Modified Sheath SystemQJP2024-10-02 View
510(k) K233329 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY2024-04-23 View
510(k) K231583 Route 92 Medical Full Length 054 Access SystemQJP2023-08-15 View
510(k) K223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY2023-04-11 View
510(k) K222743 Route 92 Medical Full Length 070 Access SystemQJP2022-10-04 View
510(k) K210635 Route 92 Medical Full Length 088 Access SystemQJP2021-07-27 View
510(k) K203043 Route 92 Medical 070 Access SystemQJP2020-11-11 View
510(k) K200121 Route 92 Medical 088 Access System, 110 cmQJP2020-04-18 View
510(k) K191717 Route 92 Medical Sheath SystemDQY2020-01-13 View
510(k) K190431 Route 92 Medical Delivery CatheterDQY2019-03-21 View
510(k) K182512 Route 92 Medical Delivery CatheterDQY2018-12-10 View
510(k) K180201 Route 92 Medical Access SystemDQY2018-05-23 View
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