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FDA 510(k)

AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

K-Number: K090168 · 2009-03-12

ApplicantMicroVention, Inc.
Decision Date2009-03-12
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2009-03-12 under 510(k) number K090168. 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 AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415?

AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 is a medical device that received FDA 510(k) clearance on 2009-03-12. The listed applicant is MicroVention, Inc.. The 510(k) number is K090168.

When did AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 receive FDA 510(k) clearance?

AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 received FDA 510(k) clearance on 2009-03-12, under 510(k) number K090168.

Who is the listed applicant for AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415?

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 DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415?

The FDA product code for AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 is HCG.

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Related Devices (Code: HCG)

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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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