Cleared Traditional

K223050 - AZUR HydroPack 18 (45-880005 (FDA 510(k) Clearance)

Also includes:
45-880010 45-880020 45-880035 45-880050 45-880060)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223050 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
83d
Days
Class 2
Risk

K223050 is an FDA 510(k) clearance for the AZUR HydroPack 18 (45-880005. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on December 21, 2022 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all MicroVention, Inc. devices

Submission Details

510(k) Number K223050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date December 21, 2022
Days to Decision 83 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 127
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