ANNULUS VALVULOTOME— 510(k) K912636

Substantially Equivalent

Cardio Source

FDA 510(k) clearance K912636 for ANNULUS VALVULOTOME, Substantially Equivalent on 1991-10-18. Applicant: Cardio Source. Device class: 2.

Clearance details

Applicant: Cardio Source
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 1991-06-14
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malibu, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cardio Source

K912635 — ANNULUS DISPOSABLE VALVULOTOME1991-10-18

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