Cleared Special

K113300 - ATB ADVANCE PTA DILATATION CATHETER

K113300 is the FDA 510(k) clearance for ATB ADVANCE PTA DILATATION CATHETER by Cook, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 30-day FDA review.

K113300 · Cook, Inc. · Cardiovascular device
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Dec 2011
Decision
30d
Days
Class 2
Risk

K113300 is an FDA 510(k) clearance for the ATB ADVANCE PTA DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 30 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 Cook, Inc. devices

Submission Details

510(k) Number K113300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date December 09, 2011
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K113300.
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K112697 · Boston Scientific · Nov 2011
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
K111295 · Boston Scientific Corporation · May 2011
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K110319 · Ev3, Inc. · Apr 2011