K063217 is an FDA 510(k) clearance for the VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL). This device is classified as a Filter, Intravascular, Cardiovascular (Class II - Special Controls, product code DTK).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 12, 2007, 80 days after receiving the submission on October 24, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3375.
| 510(k) Number | K063217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 80 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 |