Cleared Traditional

K070615 - ANGIODYNAMICS

K070615 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 60-day FDA review.

K070615 · AngioDynamics, Inc. · General Hospital
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May 2007
Decision
60d
Days
Class 2
Risk

K070615 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., MORPHEUS CT 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 May 4, 2007 after a review of 60 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 K070615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date May 04, 2007
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K070615.
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
K070002 · Boston Scientific · Aug 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070613 · AngioDynamics, Inc. · Jun 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996 · C.R. Bard, Inc. · May 2007
POWERGROSHONG PICC CATHETER
K063848 · C.R. Bard, Inc. · Apr 2007
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
K063240 · C.R. Bard, Inc. · Nov 2006
LIFECATH S PICC AND MIDLINE CATHETER
K062425 · Vygon Corp. · Sep 2006