Reprocessed ViewFlex Xtra ICE Catheter— 510(k) K190478

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K190478 for Reprocessed ViewFlex Xtra ICE Catheter, Substantially Equivalent on 2019-11-14. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code OWQ
Advisory panel: Cardiovascular
Date received: 2019-02-27
Decision date: 2019-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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