Cleared Traditional

STEP-TIP CHRONIC HEMODIALYSIS CATHETER

K040666 · Arrow International, Inc. · Gastroenterology & Urology
May 2004
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K040666 is an FDA 510(k) clearance for the STEP-TIP CHRONIC HEMODIALYSIS CATHETER, 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 May 14, 2004, 60 days after receiving the submission on March 15, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K040666 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2004
Decision Date May 14, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MSD — Catheter, Hemodialysis, Implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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