Cleared Special

K113182 - EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113182 · Edwards Lifesciences, LLC · Cardiovascular device
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Dec 2011
Decision
40d
Days
Class 2
Risk

K113182 is an FDA 510(k) clearance for the EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Draper, US). The FDA issued a Cleared decision on December 7, 2011 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K113182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2011
Decision Date December 07, 2011
Days to Decision 40 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 125d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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.

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All 201
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