Cleared Special

K023504 - MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

K023504 is an FDA 510(k) clearance for MODIFICATION TO ATB ALL-TERRAIN BALLOON..., manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 26-day FDA review.

K023504 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
26d
Days
Class 2
Risk

K023504 is an FDA 510(k) clearance for the MODIFICATION TO ATB ALL-TERRAIN BALLOON 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 November 13, 2002 after a review of 26 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.

FDA 510(k) Submission Details - K023504

510(k) Number K023504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date November 13, 2002
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 404
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K023504.
FOX PLUS PTA CATHETER
K040954 · Abbott Laboratories, Inc. · May 2004
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K030742 · Cryo Vascular Systems, Inc. · Aug 2003
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
K030062 · Avantec Vascular Corp. · Apr 2003
BOLTON PTA CATHETER
K021996 · Bolton Medical, Inc. · Aug 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · Jomed AG · Apr 2002
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc. · Jan 2001
K023504 · MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Download PDF FDA Summary Cook, Inc.