K031328 is an FDA 510(k) clearance for the RECOVERY FILTER SYSTEM, MODEL RF-048F. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 25, 2003, 88 days after receiving the submission on April 28, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K031328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2003 |
| Decision Date | July 25, 2003 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| 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 |