ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI— 510(k) K912554

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K912554 for ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI, Substantially Equivalent on 1991-09-09. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 1991-06-11
Decision date: 1991-09-09
Decision: Substantially Equivalent
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.