Cleared Traditional

K963446 - KENDALL DUAL LUMEN CATHETER

K963446 is an FDA 510(k) clearance for KENDALL DUAL LUMEN CATHETER, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K963446 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
196d
Days
Class 2
Risk

K963446 is an FDA 510(k) clearance for the KENDALL DUAL LUMEN CATHETER. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 196 days - an extended review cycle.

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 Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K963446

510(k) Number K963446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date March 18, 1997
Days to Decision 196 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
66d slower than avg
Panel avg: 130d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-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 - MPB Catheter, Hemodialysis, Non-implanted

All 29
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K963446.
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · Arrow Intl., Inc. · May 1999
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
K974236 · Medical Components, Inc. · Apr 1999
NIAGARA DUAL LUMEN CATHETER
K965178 · Vas-Cath, Inc. · Aug 1997
BRAUN HEMODIALYSIS CATHETER
K952660 · B.Braun Medical, Inc. · Sep 1996
MAHURKAR 8 FR DUAL LEMEN CATHETER
K955002 · Quinton, Inc. · Sep 1996
TWIN SILICONE CATHETER
K923691 · Medical Components, Inc. · Sep 1995