MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
FDA 510(k) clearance K083711 · decided 2009-02-02
Clearance details
- K-number
- K083711
- Device name
- MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
- Applicant
- Barrx Medical, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-12-15
- Decision date
- 2009-02-02
- Days to decision
- 49 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.