Cleared Traditional

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

K190559 · AngioDynamics, Inc. · General Hospital
May 2020
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K190559 is an FDA 510(k) clearance for the SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 22, 2020, 444 days after receiving the submission on March 5, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K190559 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2019
Decision Date May 22, 2020
Days to Decision 444 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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