Cleared Traditional

K041420 - ANGIODYNAMICS

K041420 is the FDA 510(k) clearance for ANGIODYNAMICS by AngioDynamics, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K041420 · AngioDynamics, Inc. · General Hospital
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Jul 2004
Decision
59d
Days
Class 2
Risk

K041420 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 26, 2004 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 K041420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date July 26, 2004
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 180
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K041420.
TRIFUSION, MODEL 0609190/0659350
K041088 · C.R. Bard, Inc. · Nov 2004
PREMICATH, 1261.205
K041468 · Vygon Corp. · Sep 2004
PICC
K042126 · Arrow Intl., Inc. · Aug 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · C.R. Bard, Inc. · Mar 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K040446 · AngioDynamics, Inc. · Mar 2004
POLY PER-Q-CATH PICC CATHETERS
K034019 · C.R. Bard, Inc. · Jan 2004