Cleared Traditional

K002902 - TANDEM-CATH 10 FR. CATHETER SYSTEM

K002902 is an FDA 510(k) clearance for TANDEM-CATH 10 FR. CATHETER SYSTEM, manufactured by The Kendall Company. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K002902 · The Kendall Company · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
203d
Days
Class 2
Risk

K002902 is an FDA 510(k) clearance for the TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by The Kendall Company (Mansfield, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 203 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 The Kendall Company devices

FDA 510(k) Submission Details - K002902

510(k) Number K002902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date April 09, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 130d · This submission: 203d
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 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K002902.
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
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VAXCEL DIALYSIS CATHETER
K012365 · Boston Scientific Corp · Aug 2001
MEDCOMP ULTRA-FLOW CATHETER
K003207 · Medical Components, Inc. · Jun 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc. · Mar 2001
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp · Jul 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
K981125 · Medical Components, Inc. · Feb 1999