STERILEMED REPROCESSED IVUS IMAGING CATHETER— 510(k) K043453

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K043453 for STERILEMED REPROCESSED IVUS IMAGING CATHETER, Substantially Equivalent on 2005-03-01. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code OWQ
Advisory panel: Cardiovascular
Date received: 2004-12-15
Decision date: 2005-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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