Cleared Special

K131814 - AMECATH DUAL LUMEN IMPLANTED HEMODIALYS...

K131814 is an FDA 510(k) clearance for AMECATH DUAL LUMEN IMPLANTED HEMODIALYS..., manufactured by Ameco Medical Industries. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 36-day FDA review.

K131814 · Ameco Medical Industries · Gastroenterology & Urology device
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Jul 2013
Decision
36d
Days
Class 2
Risk

K131814 is an FDA 510(k) clearance for the AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Ameco Medical Industries (Monroe, US). The FDA issued a Cleared decision on July 26, 2013 after a review of 36 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 Ameco Medical Industries devices

FDA 510(k) Submission Details - K131814

510(k) Number K131814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 20, 2013
Decision Date July 26, 2013
Days to Decision 36 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
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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