K965112 is an FDA 510(k) clearance for the MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 10, 1997, 294 days after receiving the submission on December 20, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K965112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 20, 1996 |
| Decision Date | October 10, 1997 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |