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FDA 510(k)

Hilal Embolization MicroCoils

K-Number: K160219 · 2016-08-03

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

Device Summary

Hilal Embolization MicroCoils is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-08-03 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K160219.

When did Hilal Embolization MicroCoils receive FDA 510(k) clearance?

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

Who is the listed applicant for Hilal Embolization MicroCoils?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hilal Embolization MicroCoils?

The FDA product code for Hilal Embolization MicroCoils is KRD.

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Related Devices (Code: KRD)

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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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