510(k) K260012

Device: UltraScore Focused Force PTA Balloon
Applicant: Bard Peripheral Vascular, Inc.
510(k) number: K260012
Product code: PNO
Decision: Substantially Equivalent (SESE)
Decision date: 2026-02-04
Date received: 2026-01-05
Regulation: 870.1250
Classification name: Catheter, Percutaneous, Cutting/Scoring
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Laurissa Brantley
Address: 1625 W. 3rd St. Tempe AZ US 85281 85281

FDA Registration Numbers

3002807315
2183744
8043792
3016948450
3015002281
1313046
3012159165
3003775186
3027343398
1000533027
2124215
3002807314
2020394
3012696653
3005462046
1721676
3007835716
3021140368
3009756153
3015060261
3011826338
3014598164
1646831
2011171
1820334
1647149
3006082230
3030042169
1018233
3010391265
3000126629
9681260

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PNO

510(k)	Device	Applicant	Decision date
K243944	Aperta NSE PTA Balloon Dilatation Catheter	Goodman Co., Ltd.	2025-04-22
K242254	D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter	Dk Medical Technology Co., Ltd.	2025-04-21
K241478	Tri-Wedge PTA Scoring Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2024-10-22
K232258	XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter	Transit Scientific, LLC	2024-06-17
K232013	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)	Goodman Co., Ltd.	2024-03-28
K232207	D·Kutting PTA Scoring Balloon Dilatation Catheter	Dk Medical Technology Co., Ltd.	2024-03-07
K221986	XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter	Transit Scientific, LLC	2022-10-18
K220704	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2022-05-04
K213728	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2021-12-15
K203437	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2020-12-22
K202187	FLEX Vessel Prep System	Venturemed Group, Inc.	2020-09-11
K193495	XO Score Percutaneous Transluminal Angioplasty Scoring Catheter	Transit Scientific	2020-05-29
K193181	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2020-04-15
K182713	Scoreflex PTA Scoring Balloon Catheter	Orbusneich Medical Trading, Inc.	2019-06-11
K172571	ULTRASCORE Focused Force PTA Balloon	C. R. Bard	2017-09-22