Cleared Traditional

K101843 - DURAMAX CHRONIC HEMODIALYSIS CATHETER A...

K101843 is the FDA 510(k) clearance for DURAMAX CHRONIC HEMODIALYSIS CATHETER A... by AngioDynamics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K101843 · AngioDynamics, Inc. · Gastroenterology & Urology device
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Oct 2010
Decision
111d
Days
Class 2
Risk

K101843 is an FDA 510(k) clearance for the DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Latham, US). The FDA issued a Cleared decision on October 20, 2010 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 AngioDynamics, Inc. devices

Submission Details

510(k) Number K101843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 01, 2010
Decision Date October 20, 2010
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
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K101843.
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