K901659 is an FDA 510(k) clearance for the TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on November 8, 1990, 212 days after receiving the submission on April 10, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K901659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1990 |
| Decision Date | November 08, 1990 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTK — Filter, Intravascular, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3375 |