510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014195Substantially Equivalent

Kayak Hydrophilic Guide Wires

Boston Scientific Corporation, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014195 is the FDA 510(k) clearance record for KAYAK HYDROPHILIC GUIDE WIRES, a class II device, cleared for Boston Scientific Corp on under FDA product code DOX (Fluorometer, Lead (Dedicated Instruments)). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K014195.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DOX Fluorometer, Lead (Dedicated Instruments)
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Boston Scientific Corp One Scimed Pl., Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code DOX

Trailing 12 months

FDA records hold no clearances under product code DOX in the trailing twelve months.

FDA records show no clearances under product code DOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260