K052578 is an FDA 510(k) clearance for the BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J. This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on November 25, 2005, 66 days after receiving the submission on September 20, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K052578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | September 20, 2005 |
| Decision Date | November 25, 2005 |
| Days to Decision | 66 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 |