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FDA 510(k) Applications Submitted by Kathy Tansey
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.
K201518
06/08/2020
Route 92 Medical 088 Access System
Route 92 Medical
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.
K203043
10/06/2020
Route 92 Medical 070 Access System
Route 92 Medical, Inc.
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