BIRD'S NEST VENA CAVA FILTER
FDA premarket approval P850049/S009 · decided 2006-02-03
Approval details
- PMA number
- P850049
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Trade name
- BIRD'S NEST VENA CAVA FILTER
- Generic name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR
- Applicant
- Cook, Inc.
- Date received
- 2006-01-05
- Decision date
- 2006-02-03
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DTK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- CHANGE TO THE STERILIZATION TYPE WITHIN THE SAME FACILITY.
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| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
| ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020) | Cook, Inc. | 2013-10-25 |