FDA 510(k)

HILAL EMBOLIZATION MICROCOIL(TM)

K-Number: K901337 · 1990-11-13

Decision Date1990-11-13

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

HILAL EMBOLIZATION MICROCOIL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K901337. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HILAL EMBOLIZATION MICROCOIL(TM)?

HILAL EMBOLIZATION MICROCOIL(TM) is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is Cook, Inc.. The 510(k) number is K901337.

When did HILAL EMBOLIZATION MICROCOIL(TM) receive FDA 510(k) clearance?

HILAL EMBOLIZATION MICROCOIL(TM) received FDA 510(k) clearance on 1990-11-13, under 510(k) number K901337.

Who is the listed applicant for HILAL EMBOLIZATION MICROCOIL(TM)?

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

What is the FDA product code for HILAL EMBOLIZATION MICROCOIL(TM)?

The FDA product code for HILAL EMBOLIZATION MICROCOIL(TM) is HCG.

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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.