Cleared Traditional

K113658 - AMPLATZER VASCULAR PLUG 4

K113658 is an FDA 510(k) clearance for AMPLATZER VASCULAR PLUG 4, manufactured by Aga Medical Corp.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K113658 · Aga Medical Corp. · Cardiovascular device
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Jun 2012
Decision
183d
Days
Class 2
Risk

K113658 is an FDA 510(k) clearance for the AMPLATZER VASCULAR PLUG 4. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Aga Medical Corp. (Plymouth, US). The FDA issued a Cleared decision on June 12, 2012 after a review of 183 days - an extended review 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: 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 Aga Medical Corp. devices

FDA 510(k) Submission Details - K113658

510(k) Number K113658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2011
Decision Date June 12, 2012
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
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 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K113658.
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K122543 · MicroVention, Inc. · Nov 2012
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AZUR DETACHABLE 35
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K113266 · Vascular Solutions, Inc. · May 2012
INZONE DETACHMENT SYSTEM
K120816 · Stryker · Apr 2012
AZUR DETACHABLE 18
K120630 · MicroVention, Inc. · Mar 2012