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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