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FDA 510(k)

AZUR DETACHABLE 18

K-Number: K120630 · 2012-03-28

ApplicantMicroVention, Inc.
Decision Date2012-03-28
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AZUR DETACHABLE 18 is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K120630. 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 AZUR DETACHABLE 18?

AZUR DETACHABLE 18 is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is MicroVention, Inc.. The 510(k) number is K120630.

When did AZUR DETACHABLE 18 receive FDA 510(k) clearance?

AZUR DETACHABLE 18 received FDA 510(k) clearance on 2012-03-28, under 510(k) number K120630.

Who is the listed applicant for AZUR DETACHABLE 18?

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

What is the FDA product code for AZUR DETACHABLE 18?

The FDA product code for AZUR DETACHABLE 18 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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