AZUR HydroPack 18 - AZUR HydroPack 18 (45-880005

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223050

Identifiers

510(k) Number: K223050 FDA 510(k)
FDA Product Code: KRD FDA 510(k)
Models / Variants: AZUR HydroPack 18 (45-880005 FDA 510(k)
45-880010 FDA 510(k)
45-880020 FDA 510(k)
45-880035 FDA 510(k)
45-880050 FDA 510(k)
45-880060) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.3300 FDA 510(k)
Regulation Number: 870.3300 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

AZUR HydroPack 18 - AZUR HydroPack 18 (45-880005 by Microvention Inc. — Class II — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K223050	Class II	Active

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Manufacturer

Manufacturer: Microvention Inc.
FDA Applicant: MicroVention, Inc.

Sources (1)

FDA 510(k) K223050 24 fields · synced Jun 18, 2026