K042399 is an FDA 510(k) clearance for the MODIFICATION TO SHORT INTRODUCER SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Rex Medical, L.P. (Great Neck, US). The FDA issued a Cleared decision on December 17, 2004, 105 days after receiving the submission on September 3, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K042399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2004 |
| Decision Date | December 17, 2004 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |