K880860 is an FDA 510(k) clearance for the CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015. This device is classified as a Occluder, Catheter Tip (Class II — Special Controls, product code DQT).
Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on May 26, 1988, 86 days after receiving the submission on March 1, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1370.
| 510(k) Number | K880860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1988 |
| Decision Date | May 26, 1988 |
| Days to Decision | 86 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 |