Cleared Special

K122316 - AZUR DETACHABLE 35

K122316 is the FDA 510(k) clearance for AZUR DETACHABLE 35 by MicroVention, Inc.. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 28-day FDA review.

K122316 · MicroVention, Inc. · Cardiovascular device
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Aug 2012
Decision
28d
Days
Class 2
Risk

K122316 is an FDA 510(k) clearance for the AZUR DETACHABLE 35. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 29, 2012 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all MicroVention, Inc. devices

Submission Details

510(k) Number K122316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2012
Decision Date August 29, 2012
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 93
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K122316.
RETRACTA DETACHABLE EMBOLIZATION COIL
K123712 · Cook Incorporated · Jan 2013
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K122543 · MicroVention, Inc. · Nov 2012
AZUR CX DETACHABLE 18
K123384 · MicroVention, Inc. · Nov 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266 · Vascular Solutions, Inc. · May 2012
INZONE DETACHMENT SYSTEM
K120816 · Stryker · Apr 2012
AZUR DETACHABLE 18
K120630 · MicroVention, Inc. · Mar 2012