K961246
Substantially Equivalent - Subject to Tracking Reg.SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
- Applicant
- St. Jude Medical, Inc.
- Product code
- KRH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- St. Paul, MN, 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.