DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H— 510(k) K980534
Substantially EquivalentThe Heart Valve Div. Medtronic Cardiovascular Surg
FDA 510(k) clearance K980534 for DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H, Substantially Equivalent on 1998-04-30. Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg.
Clearance details
- Applicant
- The Heart Valve Div. Medtronic Cardiovascular Surg
- Product code
- Code KRH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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.