ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
FDA 510(k) clearance K121048 · decided 2012-08-03
Clearance details
- K-number
- K121048
- Device name
- ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-04-06
- Decision date
- 2012-08-03
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- JCT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.