Cleared Traditional

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

K232013 · Goodman Co., Ltd. · Cardiovascular

Mar 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K232013 is an FDA 510(k) clearance for the Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040), a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Goodman Co., Ltd. (Nagoya, JP). The FDA issued a Cleared decision on March 28, 2024, 266 days after receiving the submission on July 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K232013 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2023
Decision Date	March 28, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PNO — Catheter, Percutaneous, Cutting/scoring
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material