K915496 is an FDA 510(k) clearance for the DESERET GUIDEWIRE INTRODUCER. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on February 27, 1992, 80 days after receiving the submission on December 9, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K915496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1991 |
| Decision Date | February 27, 1992 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |