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FDA 510(k)

PTFE Guidewire

K-Number: K242824 · 2024-12-06

ApplicantLake Region Medical
Decision Date2024-12-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTFE Guidewire is a medical device manufactured by Lake Region Medical. It received FDA 510(k) clearance on 2024-12-06 under approval number K242824. 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 PTFE Guidewire?

PTFE Guidewire is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Lake Region Medical. The 510(k) number is K242824.

When was PTFE Guidewire approved by the FDA?

PTFE Guidewire received FDA 510(k) clearance on 2024-12-06, under approval number K242824.

What company makes PTFE Guidewire?

PTFE Guidewire is manufactured by Lake Region Medical.

What is the FDA product code for PTFE Guidewire?

The FDA product code for PTFE Guidewire is DQX.

Other Devices by Lake Region Medical

K160643ENROUTE 0.014 Guidewire K211741Pre-Formed Extra Support Guidewire K221575Pre-Formed Blue K253746Enroute 0.014'' Transcarotid Guidewire

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.

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