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510(k) K203043

Route 92 Medical 070 Access System by Route 92 Medical, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 2020
Date Received
October 6, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Neurovasculature
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

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  • K222743 — Route 92 Medical Full Length 070 Access System (October 4, 2022)
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  • K200121 — Route 92 Medical 088 Access System, 110 cm (April 18, 2020)
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