BIO-SEAL LUNG BIOPSY TRACT SYSTEM
Absorbable Lung Biopsy Plug
ANGIOTECH
The following data is part of a De Novo classification by Angiotech with the FDA for Bio-seal Lung Biopsy Tract System.
Pre-market Notification Details
| DeNovo ID | DEN090007 |
| Device Name: | BIO-SEAL LUNG BIOPSY TRACT SYSTEM |
| Classification | Absorbable Lung Biopsy Plug |
| Applicant | ANGIOTECH 1618 Station Street Vancouver, Bc, CA V6a 1b6 |
| Contact | Trudy Estridge |
| Product Code | OMT |
| CFR Regulation Number | 878.4755 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K082438 |
| Review Advisory Board | Anesthesiology |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2009-04-17 |
| Decision Date | 2012-12-19 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| 10848782023148 |
DEN090007 |
000 |
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