COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600— 510(k) K923367

Unknown

Baxter Healthcare Corp

FDA 510(k) clearance K923367 for COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600, Unknown on 1993-01-06. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 1992-07-09
Decision date: 1993-01-06
Decision: Unknown
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.