DISPOSABLE HOLDER FOR BIOPROSTHESIS— 510(k) K790022

Name: FDA 510(k) clearance K790022
Creator: U.S. Food and Drug Administration
Published: 1979-01-15

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K790022 for DISPOSABLE HOLDER FOR BIOPROSTHESIS, Substantially Equivalent on 1979-01-15. Applicant: Edwards Laboratories. Device class: 1.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DTJ
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1979-01-03
Decision date: 1979-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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

More clearances from Edwards Laboratories

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K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR1980-07-28
K800655 — MODEL 100 SPECTRAVIEW1980-04-16
K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY1980-03-17
K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER1979-12-07
K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A1979-02-26

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