Cleared Special

K052036 - ATB ADVANCE PTA DILATATION CATHETER

K052036 is the FDA 510(k) clearance for ATB ADVANCE PTA DILATATION CATHETER by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 28-day FDA review.

K052036 · Cook, Inc. · Cardiovascular device

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Aug 2005

Decision

28d

Days

Class 2

Risk

K052036 is an FDA 510(k) clearance for the ATB ADVANCE PTA DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 25, 2005 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 Cook, Inc. devices

Submission Details

510(k) Number	K052036 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 2005
Decision Date	August 25, 2005
Days to Decision	28 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

97d faster than avg

Panel avg: 125d · This submission: 28d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 577

Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K052036.

ASAHI TORNUS SUPPORT CATHETER

K051772 · Asahi Intecc Co., Ltd. · Sep 2005

EDWARDS PERIPHERAL DILATION CATHETER

K052149 · Edwards Lifesciences, LLC · Sep 2005

MODIFIED CONCENTRIC RETRIEVER, MODEL 90039

K051838 · Concentric Medical, Inc. · Sep 2005

BARD ATLAS PTA BALLOON DILATATION CATHETER

K052236 · Bard Peripheral Vascular, Inc. · Aug 2005

7F SHERPA NX GUIDE CATHETER

K051846 · Medtronic Vascular · Aug 2005

MINI GHOST PTA CATHETER, MODEL 507

K051343 · NuMED, Inc. · Jul 2005

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K052036

Cook, Inc.

Bloomington, IN · US

KAREN BRADBURN

Regulatory profile

190 submissions 179 cleared

94% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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