CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE— 510(k) K942736

Name: FDA 510(k) clearance K942736
Creator: U.S. Food and Drug Administration
Published: 1994-07-06

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K942736 for CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE, Substantially Equivalent on 1994-07-06. Applicant: Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code DTJ
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1994-06-10
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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