Cleared Special

K141051 - VECTORFLOW

Also marketed or referenced as:
ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU

K141051 is an FDA 510(k) clearance for VECTORFLOW, manufactured by Arrow International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 74-day FDA review.

K141051 · Arrow International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
74d
Days
Class 2
Risk

K141051 is an FDA 510(k) clearance for the VECTORFLOW. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on July 7, 2014 after a review of 74 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 Arrow International, Inc. devices

FDA 510(k) Submission Details - K141051

510(k) Number K141051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date July 07, 2014
Days to Decision 74 days
Submission Type Special
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
57d faster than avg
Panel avg: 131d · This submission: 74d
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 92
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K141051.
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