REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER— 510(k) K100254

Substantially Equivalent

Ascent Healthcare Solutions

FDA 510(k) clearance K100254 for REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 2010-05-28. Applicant: Ascent Healthcare Solutions.

Clearance details

Applicant: Ascent Healthcare Solutions
Product code: Code NLH
Advisory panel: Cardiovascular
Date received: 2010-01-28
Decision date: 2010-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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