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

FDA 510(k) Number Submission Date Device Name Applicant
K200121 01/21/2020 Route 92 Medical 088 Access System, 110 cm Route 92 Medical Inc.
K190431 02/22/2019 Route 92 Medical Delivery Catheter Route 92 Medical Inc.
K191717 06/26/2019 Route 92 Medical Sheath System Route 92 Medical Inc.
K182512 09/12/2018 Route 92 Medical Delivery Catheter Route 92 Medical Inc.
K210635 03/03/2021 Route 92 Medical Full Length 088 Access System Route 92 Medical Inc.


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