MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS— 510(k) K864155

Name: FDA 510(k) clearance K864155
Creator: U.S. Food and Drug Administration
Published: 1986-11-20

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K864155 for MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS, Substantially Equivalent on 1986-11-20. Applicant: American Edwards Laboratories. Device class: 1.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DTJ
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1986-10-23
Decision date: 1986-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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K880052 — EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR1988-04-01

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K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
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