CARPENTIER-EDWARDS FLEX. ANNULOPLASTY— 510(k) K792441

Name: FDA 510(k) clearance K792441
Creator: U.S. Food and Drug Administration
Published: 1980-03-17

Substantially Equivalent - Subject to Tracking & PMS

Edwards Laboratories

FDA 510(k) clearance K792441 for CARPENTIER-EDWARDS FLEX. ANNULOPLASTY, Substantially Equivalent - Subject to Tracking & PMS on 1980-03-17. Applicant: Edwards Laboratories. Device class: 2.

Clearance details

Applicant: Edwards Laboratories
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 1979-11-29
Decision date: 1980-03-17
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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
K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER1979-12-07
K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A1979-02-26
K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS1979-01-15

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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