BIO-SEAL LUNG BIOPSY TRACT SYSTEM
FDA 510(k) clearance DEN090007 · decided 2012-12-19
Clearance details
- K-number
- DEN090007
- Device name
- BIO-SEAL LUNG BIOPSY TRACT SYSTEM
- Applicant
- Angiotech
- Decision
- Unknown
- Date received
- 2009-04-17
- Decision date
- 2012-12-19
- Days to decision
- 1342 days
- Clearance type
- Post-NSE
- Product code
- OMT
- Device class
- 2
- Regulation number
- 878.4755
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Vancouver, Bc, CA
- Third-party review
- No
- Expedited review
- No
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| Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) (K243722) | Selio Medical Limited | 2025-04-08 |
Recalls involving this device
No recalls on record reference this clearance.