K022236 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 November 27, 2002, 139 days after receiving the submission on July 11, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K022236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2002 |
| Decision Date | November 27, 2002 |
| Days to Decision | 139 days |
| Submission Type | Special |
| 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 |