Cleared Traditional

K053589 - LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING

K053589 is an FDA 510(k) clearance for LONG-TERM HEMODIALYSIS CATHETERS WITH B..., manufactured by Bard Access Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K053589 · Bard Access Systems, Inc. · Gastroenterology & Urology device
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Apr 2006
Decision
111d
Days
Class 2
Risk

K053589 is an FDA 510(k) clearance for the LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 13, 2006 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bard Access Systems, Inc. devices

FDA 510(k) Submission Details - K053589

510(k) Number K053589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date April 13, 2006
Days to Decision 111 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
20d faster than avg
Panel avg: 131d · This submission: 111d
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 99
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K053589.
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
K063431 · Spire Biomedical, Inc. · Jan 2007
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288 · Spire Biomedical, Inc. · Sep 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
K060155 · Spire Biomedical, Inc. · May 2006
MEDCOMP SPLIT CATH II
K051280 · Medcomp · Nov 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
K051584 · Kendall · Oct 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · C.R. Bard, Inc. · Aug 2005