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FDA 510(k)

Pre-Formed Blue

K-Number: K221575 · 2022-10-07

ApplicantLake Region Medical
Decision Date2022-10-07
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pre-Formed Blue is a medical device manufactured by Lake Region Medical. It received FDA 510(k) clearance on 2022-10-07 under approval number K221575. 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 Pre-Formed Blue?

Pre-Formed Blue is a medical device that received FDA 510(k) clearance on 2022-10-07. It is manufactured by Lake Region Medical. The 510(k) number is K221575.

When was Pre-Formed Blue approved by the FDA?

Pre-Formed Blue received FDA 510(k) clearance on 2022-10-07, under approval number K221575.

What company makes Pre-Formed Blue?

Pre-Formed Blue is manufactured by Lake Region Medical.

What is the FDA product code for Pre-Formed Blue?

The FDA product code for Pre-Formed Blue is DQX.

Other Devices by Lake Region Medical

K160643ENROUTE 0.014 Guidewire K211741Pre-Formed Extra Support Guidewire K242824PTFE Guidewire K253746Enroute 0.014'' Transcarotid Guidewire

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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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