Bio-Seal Lung Biopsy Tract System
by Angiotech
De Novo DEN090007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN090007 | Date19 Dec 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- OMT
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4755
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 23 Sep 2026
The Bio-Seal Lung Biopsy Tract System is an absorbable lung biopsy plug. It is a type of device used in lung biopsy procedures.
The device is supplied with a product code of OMT and is classified as a class 2 device. It has an FDA 510K authorization and is registered with the regulation number 878.4755. The device is available with various registration numbers, including 1721676, 3015225571, and 3011642792.
Other devices from Angiotech
Questions
AI-generated answers, 23 Sep 2026
What is the Bio-Seal Lung Biopsy Tract System used for?
The Bio-Seal Lung Biopsy Tract System is used in lung biopsy procedures as an absorbable lung biopsy plug.
Is the Bio-Seal Lung Biopsy Tract System supplied sterile?
The device data does not specify if the Bio-Seal Lung Biopsy Tract System is supplied sterile, but it is an absorbable plug used in medical procedures.
What are the registration numbers for the Bio-Seal Lung Biopsy Tract System?
The Bio-Seal Lung Biopsy Tract System has multiple registration numbers, including 1721676, 3015225571, and 3011642792, among others.
What is the product code for the Bio-Seal Lung Biopsy Tract System?
The product code for the Bio-Seal Lung Biopsy Tract System is OMT.