K964061 is an FDA 510(k) clearance for the GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD). This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 20, 1997, 133 days after receiving the submission on October 10, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K964061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1996 |
| Decision Date | February 20, 1997 |
| Days to Decision | 133 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 |