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510(k) K240529

8F Modified Sheath System by Route 92 Medical, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2024
Date Received
February 23, 2024
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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  • K231583 — Route 92 Medical Full Length 054 Access System (August 15, 2023)
  • K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (April 11, 2023)
  • K222743 — Route 92 Medical Full Length 070 Access System (October 4, 2022)
  • K210635 — Route 92 Medical Full Length 088 Access System (July 27, 2021)
  • K203043 — Route 92 Medical 070 Access System (November 11, 2020)
  • K201518 — Route 92 Medical 088 Access System (August 14, 2020)
  • K200121 — Route 92 Medical 088 Access System, 110 cm (April 18, 2020)
  • K191717 — Route 92 Medical Sheath System (January 13, 2020)

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  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)