VALVE SIZER— 510(k) K934951

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K934951 for VALVE SIZER, Substantially Equivalent on 1993-12-10. Applicant: Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code DTI
Device class: Class 1
Regulation: 21 CFR 870.3945
Advisory panel: Cardiovascular
Date received: 1993-10-18
Decision date: 1993-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.