Cleared Special

K101017 - ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

K101017 is an FDA 510(k) clearance for ANGIODYNAMICS, manufactured by AngioDynamics, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 66-day FDA review.

K101017 · AngioDynamics, Inc. · General Hospital
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Jun 2010
Decision
66d
Days
Class 2
Risk

K101017 is an FDA 510(k) clearance for the ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101017

510(k) Number K101017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date June 17, 2010
Days to Decision 66 days
Submission Type Special
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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 282
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K101017 · ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
Download PDF AngioDynamics, Inc.