Cleared Special

K113468 - ELM PTA BALLON DILATATION CATHETER

K113468 is an FDA 510(k) clearance for ELM PTA BALLON DILATATION CATHETER, manufactured by Creagh Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 28-day FDA review.

K113468 · Creagh Medical, Ltd. · Cardiovascular device
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Dec 2011
Decision
28d
Days
Class 2
Risk

K113468 is an FDA 510(k) clearance for the ELM PTA BALLON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Creagh Medical, Ltd. (North Reading, US). The FDA issued a Cleared decision on December 20, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Creagh Medical, Ltd. devices

FDA 510(k) Submission Details - K113468

510(k) Number K113468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2011
Decision Date December 20, 2011
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 273
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K113468.
ATLAS PTA BALLOON DILATATION CATHETER
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K111899 · Abbott Vascular · Oct 2011