K050558 is an FDA 510(k) clearance for the MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F. 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 August 29, 2005, 179 days after receiving the submission on March 3, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K050558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | March 03, 2005 |
| Decision Date | August 29, 2005 |
| Days to Decision | 179 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 |