K931464 is an FDA 510(k) clearance for the BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on October 18, 1993, 208 days after receiving the submission on March 24, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K931464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1993 |
| Decision Date | October 18, 1993 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |