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FDA 510(k)

Hilal Embolization MicroCoils

K-Number: K160219 · 2016-08-03

Decision Date2016-08-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hilal Embolization MicroCoils is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-08-03 under approval number K160219. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hilal Embolization MicroCoils?

Hilal Embolization MicroCoils is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by Cook Incorporated. The 510(k) number is K160219.

When was Hilal Embolization MicroCoils approved by the FDA?

Hilal Embolization MicroCoils received FDA 510(k) clearance on 2016-08-03, under approval number K160219.

What company makes Hilal Embolization MicroCoils?

Hilal Embolization MicroCoils is manufactured by Cook Incorporated.

What is the FDA product code for Hilal Embolization MicroCoils?

The FDA product code for Hilal Embolization MicroCoils is KRD.

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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.