K910916 is an FDA 510(k) clearance for the CATHLAB SILICONE OCCLUSION BALLOON CATHETER. This device is classified as a Occluder, Catheter Tip (Class II - Special Controls, product code DQT).
Submitted by Cathlab Corp. (Irvine, US). The FDA issued a Cleared decision on June 24, 1991, 111 days after receiving the submission on March 5, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1370.
| 510(k) Number | K910916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1991 |
| Decision Date | June 24, 1991 |
| Days to Decision | 111 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 |