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510(k) K243577

Radical the Dude 8F Guide Catheter by Maduro Medical, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2025
Date Received
November 19, 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

Other clearances by Maduro Medical, Inc.

  • K231393 — Radical the Dude 7F Guide Catheter (November 30, 2023)

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