Cleared Special

CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER (K023907) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023907 · Cordis Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
23d
Days
Class 2
Risk

K023907 is an FDA 510(k) clearance for the CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA.... Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on December 18, 2002 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology device 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 Cordis Corp. devices

Submission Details

510(k) Number K023907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date December 18, 2002
Days to Decision 23 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 130d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNQ Dilator, Esophageal

All 15
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K023907.
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc. · Jan 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · Ethicon Endo-Surgery, Inc. · Jan 2004
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · Cordis Corp. · Jan 2000
CRE(TM) BALLOON DILATATION CATHETER
K974788 · Boston Scientific Corp · Mar 1998
CRE BALLOON DILATATION CATHETER
K971320 · Boston Scientific Corp · Oct 1997