510(k) DEN090007
DEN090007 is an FDA 510(k) premarket notification submitted by Angiotech for the device "BIO-SEAL LUNG BIOPSY TRACT SYSTEM". The FDA issued a decision of De Novo Granted on December 19, 2012. The device falls under product code OMT (Absorbable Lung Biopsy Plug), a Class II device regulated under 21 CFR 878.4755. Angiotech has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 19, 2012
- Date Received
- April 17, 2009
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Lung Biopsy Plug
- Device Class
- Class II
- Regulation Number
- 878.4755
- Review Panel
- AN
- Submission Type
A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.