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510(k) K260938

PATH BGC by Crossroads Neurovascular, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
March 20, 2026
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

Other clearances by Crossroads Neurovascular, Inc.

  • K242392 — PATH BGC (May 9, 2025)

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  • K252213 — Bendit17 Microcatheter (December 3, 2025)
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