S-Wire Guidewire System
K-Number: K153397 · 2016-08-18
ApplicantConcert Medical, LLC
Decision Date2016-08-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
S-Wire Guidewire System is a medical device manufactured by Concert Medical, LLC. It received FDA 510(k) clearance on 2016-08-18 under approval number K153397. 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 S-Wire Guidewire System?
S-Wire Guidewire System is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Concert Medical, LLC. The 510(k) number is K153397.
When was S-Wire Guidewire System approved by the FDA?
S-Wire Guidewire System received FDA 510(k) clearance on 2016-08-18, under approval number K153397.
What company makes S-Wire Guidewire System?
S-Wire Guidewire System is manufactured by Concert Medical, LLC.
What is the FDA product code for S-Wire Guidewire System?
The FDA product code for S-Wire Guidewire System is DQX.
Related Clinical Trials
Other Devices by Concert Medical, LLC
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.