Cleared Traditional

K040402 - ANGIODYNAMICS

K040402 is the FDA 510(k) clearance for ANGIODYNAMICS by AngioDynamics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K040402 · AngioDynamics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
62d
Days
Class 2
Risk

K040402 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on April 19, 2004 after a review of 62 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K040402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date April 19, 2004
Days to Decision 62 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K040402.
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · Datascope Corp. · Sep 2004
15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706
K040992 · Medcomp · Jul 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · Boston Scientific Corp · May 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · Boston Scientific Corp · Mar 2004
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · C.R. Bard, Inc. · Nov 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · Boston Scientific Corp · Oct 2003