Cleared Traditional

K101843 - DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

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

K101843 · AngioDynamics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K101843

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
20d faster than avg
Panel avg: 131d · This submission: 111d
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 123
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K101843.
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
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K102043 · Rex Medical · Nov 2010
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DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
K091506 · R4 Vascular, Inc. · Jan 2010
CENTROS CHRONIC HEMODIALYSIS CATHETER SET
K092597 · Ash Access Technology, Inc. · Nov 2009
K101843 · DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
Download PDF FDA Summary AngioDynamics, Inc.