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FDA 510(k)

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

K-Number: K223050 · 2022-12-21

ApplicantMicroVention, Inc.
Decision Date2022-12-21
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K223050. 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 HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)?

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by MicroVention, Inc.. The 510(k) number is K223050.

When was AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) approved by the FDA?

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) received FDA 510(k) clearance on 2022-12-21, under approval number K223050.

What company makes AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)?

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) is manufactured by MicroVention, Inc..

What is the FDA product code for AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)?

The FDA product code for AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) is 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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