Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter— 510(k) K240826

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K240826 for Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter, Substantially Equivalent on 2024-10-11. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NLH
Advisory panel: Cardiovascular
Date received: 2024-03-26
Decision date: 2024-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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