ANNULOFLO SYSTEM— 510(k) K970375
Substantially Equivalent - Subject to Tracking Reg.Carbomedics, Inc.
FDA 510(k) clearance K970375 for ANNULOFLO SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1997-07-25. Applicant: Carbomedics, Inc..
Clearance details
- Applicant
- Carbomedics, Inc.
- Product code
- Code KRH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Austin, TX, 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.