510(k) DEN090007
- Device
- BIO-SEAL LUNG BIOPSY TRACT SYSTEM
- Applicant
- Angiotech
- 510(k) number
- DEN090007
- Product code
- OMT
- Decision
- Unknown (DENG)
- Decision date
- 2012-12-19
- Date received
- 2009-04-17
- Regulation
- 878.4755
- Classification name
- Absorbable Lung Biopsy Plug
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- TRUDY ESTRIDGE
- Address
- 1618 Station St. Vancouver, Bc CA V6A 1B6 V6A 1B6
FDA Registration Numbers#
- 3006950086
- 1721676
- 3011642792
- 1721504
- 3012536737
- 3033589330
- 1724474
- 3015309643
- 3015225571
- 2030624
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243722 | 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) | Selio Medical Limited | 2025-04-08 |