ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k) clearance K030947 · decided 2003-05-15
Clearance details
- K-number
- K030947
- Device name
- ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
- Applicant
- Alveolus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-26
- Decision date
- 2003-05-15
- Days to decision
- 50 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
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alveolus
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.