Cleared Special

VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU

K141051 · Arrow International, Inc. · Gastroenterology & Urology

Jul 2014

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K141051 is an FDA 510(k) clearance for the VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on July 7, 2014, 74 days after receiving the submission on April 24, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K141051 FDA.gov
FDA Decision	Cleared 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