K945963 is an FDA 510(k) clearance for the THE OMNIGUIDE GUIDING CATHETER WITH BALLOON. This device is classified as a Occluder, Catheter Tip (Class II - Special Controls, product code DQT).
Submitted by Micro Interventional Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 8, 1995, 63 days after receiving the submission on December 7, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1370.
| 510(k) Number | K945963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1994 |
| Decision Date | February 08, 1995 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQT — Occluder, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1370 |