Cleared Traditional

K040492 - VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER

K040492 is an FDA 510(k) clearance for VAXCEL PLUS CHRONIC DIALYSIS CATHETER T..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K040492 · Boston Scientific Corp · Gastroenterology & Urology device
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Mar 2004
Decision
19d
Days
Class 2
Risk

K040492 is an FDA 510(k) clearance for the VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 16, 2004 after a review of 19 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K040492

510(k) Number K040492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date March 16, 2004
Days to Decision 19 days
Submission Type Traditional
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
112d faster than avg
Panel avg: 131d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 98
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K040492.
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
K040666 · Arrow International, Inc. · May 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
K040402 · AngioDynamics, Inc. · Apr 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
K040509 · Spire Biomedical, Inc. · Apr 2004
CANNON II PLUS
K040078 · Arrow International, Inc. · Feb 2004
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
K032061 · Spire Biomedical, Inc. · Dec 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · C.R. Bard, Inc. · Nov 2003