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510(k) K251372

VersaD Delivery Catheter by Unity Medical, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
May 2, 2025
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 Unity Medical, Inc.

  • K242051 — VersaD Delivery Catheter (January 17, 2025)

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