Cleared Special

K040260 - INTEGRAL HEMODIALYSIS CATHETER

K040260 is an FDA 510(k) clearance for INTEGRAL HEMODIALYSIS CATHETER, manufactured by Arrow Int'L.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 30-day FDA review.

K040260 · Arrow Int'L. · Gastroenterology & Urology device
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Mar 2004
Decision
30d
Days
Class 2
Risk

K040260 is an FDA 510(k) clearance for the INTEGRAL HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Arrow Int'L. (Reading, US). The FDA issued a Cleared decision on March 5, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Arrow Int'L. devices

FDA 510(k) Submission Details - K040260

510(k) Number K040260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2004
Decision Date March 05, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K040260.
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ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
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K040492 · Boston Scientific Corp · Mar 2004
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · C.R. Bard, Inc. · Nov 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · Boston Scientific Corp · Oct 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · C.R. Bard, Inc. · Aug 2003