DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM— 510(k) K000651
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K000651 for DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM, Substantially Equivalent on 2000-11-24. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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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.