Mechanical Guidewire
K-Number: K221351 · 2022-12-19
ApplicantBaylis Medical Company, Inc.
Decision Date2022-12-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Mechanical Guidewire is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2022-12-19 under approval number K221351. 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 Mechanical Guidewire?
Mechanical Guidewire is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K221351.
When was Mechanical Guidewire approved by the FDA?
Mechanical Guidewire received FDA 510(k) clearance on 2022-12-19, under approval number K221351.
What company makes Mechanical Guidewire?
Mechanical Guidewire is manufactured by Baylis Medical Company, Inc..
What is the FDA product code for Mechanical Guidewire?
The FDA product code for Mechanical Guidewire is DQX.
Related Clinical Trials
Other Devices by Baylis Medical Company, Inc.
K161878PORTAGE System
K161949OsteoCool V-3 RF Ablation System
K191546Epicardial Access System
K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
K183655VersaCross Transseptal Sheath
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.