Fixed Core Wire Guides
K-Number: K171764 · 2018-03-09
ApplicantCook Incorporated
Decision Date2018-03-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Fixed Core Wire Guides is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-03-09 under approval number K171764. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fixed Core Wire Guides?
Fixed Core Wire Guides is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Cook Incorporated. The 510(k) number is K171764.
When was Fixed Core Wire Guides approved by the FDA?
Fixed Core Wire Guides received FDA 510(k) clearance on 2018-03-09, under approval number K171764.
What company makes Fixed Core Wire Guides?
Fixed Core Wire Guides is manufactured by Cook Incorporated.
What is the FDA product code for Fixed Core Wire Guides?
The FDA product code for Fixed Core Wire Guides is DQX.
Related Clinical Trials
Other Devices by Cook Incorporated
Related Devices (Code: DQX)
K160785Worker GuidewireArgon Medical Devices, Inc.
K161702Endura guidewireVascular Solutions, Inc.
K160594MRWire Guide WireNano4imaging GmbH
K160643ENROUTE 0.014 GuidewireLake Region Medical
K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd.
K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.