K964284 is an FDA 510(k) clearance for the STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 6, 1997, 70 days after receiving the submission on October 28, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K964284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1996 |
| Decision Date | January 06, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTK — Filter, Intravascular, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3375 |