Cleared Traditional

K132083 - AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

K132083 is an FDA 510(k) clearance for AZUR PURE PERIPHERAL COIL SYSTEMS, manufactured by MicroVention, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K132083 · MicroVention, Inc. · Cardiovascular device
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Oct 2013
Decision
115d
Days
Class 2
Risk

K132083 is an FDA 510(k) clearance for the AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 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 October 28, 2013 after a review of 115 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all MicroVention, Inc. devices

FDA 510(k) Submission Details - K132083

510(k) Number K132083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2013
Decision Date October 28, 2013
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 99
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K132083.
GEL-BEAD EMBOLIZATION SPHERES
K133237 · Vascular Solutions, Inc. · Apr 2014
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
K133626 · MicroVention, Inc. · Dec 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · Boston Scientific Corp · Nov 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · Boston Scientific Corp · Sep 2013
AZUR PUSHABLE 18 & 35 SYSTEM
K130577 · MicroVention, Inc. · Jun 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
K123712 · Cook Incorporated · Jan 2013