Cleared Traditional

K132083 - AZUR PURE PERIPHERAL COIL SYSTEMS

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

K132083 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 92
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