K020333 is an FDA 510(k) clearance for the ATRION MEDICAL QL FLUID DISPENSING SYRINGE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on April 25, 2002, 84 days after receiving the submission on January 31, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K020333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2002 |
| Decision Date | April 25, 2002 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |