510(k) K260304

Device: WAVE PTA Balloon Catheter
Applicant: WAVE Medical AG
510(k) number: K260304
Product code: LIT
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-20
Date received: 2026-01-30
Regulation: 870.1250
Classification name: Catheter, Angioplasty, Peripheral, Transluminal
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Kym Rupp
Address: Industrieplatz 1e Bldg. 53 Neuhausen Am Rheinfall CH 8212 8212

FDA Registration Numbers

3000247873
1000563940
3012050423
1028232
1318694
9617601
2024024
2528981
3014656749
9614654
9618000
3003775186
3011088743
3015190176
3009965866
3002807314
3030574705
1000121056
3006550224
3016591327
2011171
1319639
1018233
1054241
3008700817
3002807090
1225687
1721686
1219930
3015002281
9616666
1313046
3005994106
3010220595
2183870
3005580113
3010273872
3009018440
2124215
1055236
2020394
3014222368
1016427
9617592
3014687026
2939561
3021140368
3015453963
3016927279
1643817
1820334
3013944123
3010391265
3013391155
3010291427
3002807315
3011471056
3016678045
2134265
3008261722
3014390222
1043214
2030598
3027343398
1000393132
1647149
3006082230
3016761372
9681477
9681260
3008361782
3011142981
2183744
1220452
3012448339
3004091615
3027395815
3015910259
3004730544
3004415014

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LIT

510(k)	Device	Applicant	Decision date
K252512	Armada 14 NC PTA Catheter	ABBOTT MEDICAL	2026-02-13
K251915	Amethyst HP PTA OTW 0.035 Catheter	Natec Medical , Ltd.	2025-12-18
K250706	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	Biotronik, Inc.	2025-04-04
K243704	Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2025-02-27
K241040	Amethyst HP PTA OTW 0.035 Catheter	Natec Medical , Ltd.	2024-12-18
K242419	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	Creagh Medical Ltd. Dba Surmodics, Inc.	2024-11-15
K241740	Finesse Injectable PTA Balloon Dilatation Catheter	Summa Therapeutics	2024-07-16
K241711	Oscar Peripheral Multifunctional Catheter system	Biotronik, Inc.	2024-07-11
K241683	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314	Boston Scientific Corporation	2024-07-10
K241025	JADE PLUS PTA Balloon Dilatation Catheter	OrbusNeich Medical (Shenzhen) Co., Ltd.	2024-06-11
K231402	HP PTA Balloon Dilatation Catheter	Kossel Medtech (Suzhou) Co., Ltd.	2023-12-20
K230263	Finesse Injectable PTA Balloon Dilatation Catheter	Summa Therapeutics, LLC	2023-05-26
K214009	D·Kaptain PTA High Pressure Balloon Dilatation Catheter	Dk Medical Technology Co., Ltd.	2023-04-05
K230191	Arise UHP Dilatation Catheter	Creagh Medical, Ltd.	2023-03-22
K222065	Passeo-35 Xeo Peripheral Dilatation Catheter	Biotronik, Inc.	2023-02-16