K000651
Substantially EquivalentDETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
- Applicant
- Cook, Inc.
- Product code
- HCG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.