FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Filter, Intravascular, Cardiovascular
PMA: P850049
·
Decision Apr 26, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Filter, Intravascular, Cardiovascular
- Trade Name
- COOK BIRD'S NEST VENA CAVA FILTER
- PMA Number
- P850049
- Device Class
- FDA Class 2
- Product Code
- DTK
- Generic Name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Regulation Number
- 870.3375
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- April 26, 1989
- Date Received
- July 10, 1985
- Expedited Review
- N
- Docket Number
- 89M-0193
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | FDA class 2 | Cardiovascular |