FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
BIO-SEAL LUNG BIOPSY TRACT SYSTEM
K Number: DEN090007
·
Decision Dec 19, 2012
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
1
Applicant Total
7
Review Days
1342
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Basic Information
- Device Name
- BIO-SEAL LUNG BIOPSY TRACT SYSTEM
- K Number
- DEN090007
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 878.4755
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Angiotech
- Date Received
- April 17, 2009
- Decision Date
- December 19, 2012
- Product Code
- OMT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMT | Absorbable Lung Biopsy Plug | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMT), ordered by most recent decision date.
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| K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) | Jul 13, 2012 | Substantially Equivalent |
| K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) | Feb 1, 2012 | Substantially Equivalent |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | Jan 20, 2012 | Substantially Equivalent |
| K073672 | SKATER BILIARY CATHETER | Jan 24, 2008 | Substantially Equivalent |
| K070610 | SKATER BILIARY CATHETER | Jun 21, 2007 | Substantially Equivalent |