FDA 510(k) Applications Submitted by Route 92 Medical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K203043 10/06/2020 Route 92 Medical 070 Access System Route 92 Medical, Inc.
K180201 01/24/2018 Route 92 Medical Access System Route 92 Medical, Inc.
K231583 05/31/2023 Route 92 Medical Full Length 054 Access System Route 92 Medical, Inc.
K222743 09/09/2022 Route 92 Medical Full Length 070 Access System Route 92 Medical, Inc.
K223530 11/23/2022 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set Route 92 Medical, Inc.


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