POSTERIOR ANNULOPLASTY BAND (MODEL 607)— 510(k) K960356
Substantially Equivalent - Subject to Tracking Reg.The Heart Valve Div. Medtronic Cardiovascular Surg
FDA 510(k) clearance K960356 for POSTERIOR ANNULOPLASTY BAND (MODEL 607), Substantially Equivalent - Subject to Tracking Reg. on 1996-08-27. 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 - Subject to Tracking Reg.
- 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.