K014195 is an FDA 510(k) clearance for the KAYAK HYDROPHILIC GUIDE WIRES. This device is classified as a Fluorometer, Lead (dedicated Instruments) (Class II - Special Controls, product code DOX).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on March 19, 2002, 88 days after receiving the submission on December 21, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3550.
| 510(k) Number | K014195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2001 |
| Decision Date | March 19, 2002 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DOX — Fluorometer, Lead (dedicated Instruments) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3550 |