Cleared Traditional

K060972 - KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)

K060972 is an FDA 510(k) clearance for KEDALL 14.5 FR CHRONIC HEMODIALYSIS CAT..., manufactured by Kendall. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K060972 · Kendall · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
119d
Days
Class 2
Risk

K060972 is an FDA 510(k) clearance for the KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PAL.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 119 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 Kendall devices

FDA 510(k) Submission Details - K060972

510(k) Number K060972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2006
Decision Date August 04, 2006
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 131d · This submission: 119d
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 112
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K060972.
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
K063431 · Spire Biomedical, Inc. · Jan 2007
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
K062671 · Kendall · Nov 2006
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
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
K053589 · Bard Access Systems, Inc. · Apr 2006
MEDCOMP SPLIT CATH II
K051280 · Medcomp · Nov 2005