CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS— 510(k) K914972
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K914972 for CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS, Substantially Equivalent on 1992-01-09. 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
Recent devices under product code KRH
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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.