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510(k) K253975

Radical 6F Access Catheter by Maduro Medical, Inc. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2026
Date Received
December 11, 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 Maduro Medical, Inc.

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  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)