FDA 510(k)

Savion DLVR Guidewire, Savion FLX Guidewire

K-Number: K180726 · 2018-06-18

Decision Date2018-06-18

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Savion DLVR Guidewire, Savion FLX Guidewire is a medical device manufactured by Boston Scientific, Inc.. It received FDA 510(k) clearance on 2018-06-18 under approval number K180726. 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 Savion DLVR Guidewire, Savion FLX Guidewire?

Savion DLVR Guidewire, Savion FLX Guidewire is a medical device that received FDA 510(k) clearance on 2018-06-18. It is manufactured by Boston Scientific, Inc.. The 510(k) number is K180726.

When was Savion DLVR Guidewire, Savion FLX Guidewire approved by the FDA?

Savion DLVR Guidewire, Savion FLX Guidewire received FDA 510(k) clearance on 2018-06-18, under approval number K180726.

What company makes Savion DLVR Guidewire, Savion FLX Guidewire?

Savion DLVR Guidewire, Savion FLX Guidewire is manufactured by Boston Scientific, Inc..

What is the FDA product code for Savion DLVR Guidewire, Savion FLX Guidewire?

The FDA product code for Savion DLVR Guidewire, Savion FLX 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.