TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
FDA 510(k) clearance K901659 · decided 1990-11-08
Clearance details
- K-number
- K901659
- Device name
- TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-04-10
- Decision date
- 1990-11-08
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- DTK
- Device class
- 2
- Regulation number
- 870.3375
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M00 recall (Z-0300-06) | Boston Scientific Scimed | 2005-12-23 |