TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
FDA 510(k) clearance K030963 · decided 2003-06-20
Clearance details
- K-number
- K030963
- Device name
- TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- Applicant
- Cordis Neurovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-27
- Decision date
- 2003-06-20
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami Lake, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.