ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI— 510(k) K912554
Substantially EquivalentBaxter 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. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code KRH
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- 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, through . 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.