K910339 is an FDA 510(k) clearance for the AVD INTIMAX OCCLUSION CATHETER. This device is classified as a Occluder, Catheter Tip (Class II - Special Controls, product code DQT).
Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 29, 1991, 121 days after receiving the submission on January 28, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1370.
| 510(k) Number | K910339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1991 |
| Decision Date | May 29, 1991 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQT — Occluder, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1370 |