Cleared Special

K130577 - AZUR PUSHABLE 18 & 35 SYSTEM

K130577 is an FDA 510(k) clearance for AZUR PUSHABLE 18 & 35 SYSTEM, manufactured by MicroVention, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 104-day FDA review.

K130577 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
104d
Days
Class 2
Risk

K130577 is an FDA 510(k) clearance for the AZUR PUSHABLE 18 & 35 SYSTEM. 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 June 17, 2013 after a review of 104 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130577

510(k) Number K130577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2013
Decision Date June 17, 2013
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

KRD Device Classification - Class 2, Special Controls

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 129
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K130577.
EMBOZENE MICROSPHERES
K132675 · Celonova Biosciences, Inc. · Oct 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · Boston Scientific Corp · Sep 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K123803 · Reverse Medical Corporation · Jul 2013
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
K130307 · Celonova Biosciences, Inc. · Mar 2013
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
K130577 · AZUR PUSHABLE 18 & 35 SYSTEM
Download PDF FDA Summary MicroVention, Inc.