Cleared Special

K051748 - HEMOGLIDE SERIES AND HEMOGLIDE STAR SER...

K051748 is the FDA 510(k) clearance for HEMOGLIDE SERIES AND HEMOGLIDE STAR SER... 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 44-day FDA review.

K051748 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
44d
Days
Class 2
Risk

K051748 is an FDA 510(k) clearance for the HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS. 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 August 12, 2005 after a review of 44 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 K051748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date August 12, 2005
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
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 K051748.
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc. · Feb 2009
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400 · AngioDynamics, Inc. · May 2008
MEDCOMP SPLIT CATH II
K051280 · Medcomp · Nov 2005
MEDCOMP SPLIT-CATH II
K040318 · Medcomp · Feb 2005
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
K040328 · Medcomp · Nov 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · Datascope Corp. · Sep 2004