CENTRI-SAFE(TM) VALVE— 510(k) K921500

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K921500 for CENTRI-SAFE(TM) VALVE, Substantially Equivalent on 1992-09-15. Applicant: Cardio Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cardio Systems, Inc.
Product code: Code MJJ
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1992-03-31
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conshohocken, PA, 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.