510(k) K014195

Device: KAYAK HYDROPHILIC GUIDE WIRES
Applicant: BOSTON SCIENTIFIC CORP.
510(k) number: K014195
Product code: DOX
Decision: Substantially Equivalent (SESE)
Decision date: 2002-03-19
Date received: 2001-12-21
Regulation: 862.3550
Classification name: Fluorometer, Lead (dedicated Instruments)
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARK MURPHY
Address: One Scimed Pl. Maple Grove MN US 55311 55311

FDA Registration Numbers#

3003915875
1625425

Source Documents#

Other 510(k) Records For Product Code DOX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K944226	MSI PROCEDURE KIT	Msi, Inc.	1995-06-21
K900822	HYDRO-SIL(TM) COATED GUIDEWIRES	National-Standard Medical Products	1990-07-17
K832030	HEPARIN COATED STAINLESS STEEL/TEFLON	Argon Medical Corp.	1983-09-29

Legacy Summary#

summary

FDA Review#

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