FDA 510(k)

Pre-Formed Extra Support Guidewire

K-Number: K211741 · 2021-11-22

Decision Date2021-11-22

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Pre-Formed Extra Support Guidewire is a medical device manufactured by Lake Region Medical. It received FDA 510(k) clearance on 2021-11-22 under approval number K211741. 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 Extra Support Guidewire?

Pre-Formed Extra Support Guidewire is a medical device that received FDA 510(k) clearance on 2021-11-22. It is manufactured by Lake Region Medical. The 510(k) number is K211741.

When was Pre-Formed Extra Support Guidewire approved by the FDA?

Pre-Formed Extra Support Guidewire received FDA 510(k) clearance on 2021-11-22, under approval number K211741.

What company makes Pre-Formed Extra Support Guidewire?

Pre-Formed Extra Support Guidewire is manufactured by Lake Region Medical.

What is the FDA product code for Pre-Formed Extra Support Guidewire?

The FDA product code for Pre-Formed Extra Support Guidewire is DQX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.