510(k) K231402

Device: HP PTA Balloon Dilatation Catheter
Applicant: Kossel Medtech (Suzhou) Co., Ltd.
510(k) number: K231402
Product code: LIT
Decision: Substantially Equivalent (SESE)
Decision date: 2023-12-20
Date received: 2023-05-15
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
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: Ron Lv
Address: Bldg. 6, # 8, Jinfeng Rd. Suzhou CN 215163 215163

FDA Registration Numbers

3002807090
3027343398
3014687026
3010391265
9617592
3002807315
3016927279
2183870
3015453963
2183744
3010291427
2134265
3008700817
1318694
3016591327
3021140368
2024168
1225687
1721676
1820334
2939561
3015910259
3000247873
2024024
3002807314
1018233
3003775186
3014656749
1043214
3027395815
1055236
3007738736
9616666
1028232
3013391155
1000393132
2134626
1319639
3004091615
9681477
9614654
3011088743
3004730544
1000563940
3009018440
3010432890
3005580113
3016761372
1647149
3005718570
9617601
3010273872
2030598
3014390222
2020394
3011471056
3011142981
1643817
1721686
9681260
2124215
3013944123
3010220595
3015002281
1282497
1313046
3009965866
9618000
3004415014
3012448339
1054241
3008261722
3016678045
3030574705
3002806603
3006550224
8043892
3009564766
3005994106
3006082230

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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
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
K223177	Highlander 014 PTA Balloon Dilatation Catheter	C.R. Bard, Inc.	2023-01-20