Cleared Special

K012365 - VAXCEL DIALYSIS CATHETER

K012365 is an FDA 510(k) clearance for VAXCEL DIALYSIS CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 29-day FDA review.

K012365 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Aug 2001
Decision
29d
Days
Class 2
Risk

K012365 is an FDA 510(k) clearance for the VAXCEL DIALYSIS CATHETER. 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 August 24, 2001 after a review of 29 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K012365

510(k) Number K012365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date August 24, 2001
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
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 98
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K012365.
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
K011916 · Horizon Medical Products, Inc. · Oct 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · Medcomp · Oct 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · Medical Components, Inc. · Oct 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · Medical Components, Inc. · Jun 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc. · Mar 2001
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp · Jul 1999