FDA.reportPublic FDA data

510(k) K232013

Device
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, AW
Applicant
Goodman Co., Ltd.
510(k) number
K232013
Product code
PNO
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-28
Date received
2023-07-06
Regulation
870.1250
Classification name
Catheter, Percutaneous, Cutting/Scoring
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Aida Kanechika
Address
5f Kdx Nagoya Sakae Bldg. 4-5-3 Sakae, Naka-Ku Nagoya JP 460-0008 460-0008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.2026-02-04
K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.2025-04-22
K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2025-04-21
K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2024-10-22
K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC2024-06-17
K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2024-03-07
K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC2022-10-18
K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2022-05-04
K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2021-12-15
K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-12-22
K202187FLEX Vessel Prep SystemVenturemed Group, Inc.2020-09-11
K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific2020-05-29
K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC2020-04-15
K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.2019-06-11
K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard2017-09-22