Cleared Special

K033294 - HEMOSPLIT XK

Also marketed or referenced as:
16FR X 19 CM, KIT WITH MICROINTRODUCER

K033294 is the FDA 510(k) clearance for HEMOSPLIT XK by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Special 510(k) pathway after a 43-day FDA review.

K033294 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
43d
Days
Class 2
Risk

K033294 is an FDA 510(k) clearance for the HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 43 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K033294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 14, 2003
Decision Date November 26, 2003
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K033294.
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
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ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
K040402 · AngioDynamics, Inc. · Apr 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · Boston Scientific Corp · Mar 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · Boston Scientific Corp · Oct 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · C.R. Bard, Inc. · Aug 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
K030020 · C.R. Bard, Inc. · Jun 2003