Cleared Special

K141360 - TRIPLEPLAY PRO

K141360 is an FDA 510(k) clearance for TRIPLEPLAY PRO, manufactured by Wildcat Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 20-day FDA review.

K141360 · Wildcat Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2014
Decision
20d
Days
Class 2
Risk

K141360 is an FDA 510(k) clearance for the TRIPLEPLAY PRO. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Wildcat Medical, Inc. (Tulsa, US). The FDA issued a Cleared decision on June 12, 2014 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Wildcat Medical, Inc. devices

FDA 510(k) Submission Details - K141360

510(k) Number K141360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date June 12, 2014
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 126
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