The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Kayak Hydrophilic Guide Wires.
| Device ID | K014195 |
| 510k Number | K014195 |
| Device Name: | KAYAK HYDROPHILIC GUIDE WIRES |
| Classification | Fluorometer, Lead (dedicated Instruments) |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Mark Murphy |
| Correspondent | Mark Murphy BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DOX |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-03-19 |
| Summary: | summary |