K901235 is an FDA 510(k) clearance for the GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER. 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 October 9, 1990, 209 days after receiving the submission on March 14, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K901235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1990 |
| Decision Date | October 09, 1990 |
| Days to Decision | 209 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 |