Cleared Special

K041006 - TANDEM-CATH HEMODIALYSIS CATHETER

K041006 is an FDA 510(k) clearance for TANDEM-CATH HEMODIALYSIS CATHETER, manufactured by Kendall. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 30-day FDA review.

K041006 · Kendall · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
30d
Days
Class 2
Risk

K041006 is an FDA 510(k) clearance for the TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 30 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 Kendall devices

FDA 510(k) Submission Details - K041006

510(k) Number K041006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date May 19, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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
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