K093830 is an FDA 510(k) clearance for the MEDLINE ANGIOGRAPHIC CONTROL SYRINGE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 3, 2011, 444 days after receiving the submission on December 14, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K093830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2009 |
| Decision Date | March 03, 2011 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |