510(k) K252512
- Device
- Armada 14 NC PTA Catheter
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K252512
- Product code
- LIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-13
- Date received
- 2025-08-11
- 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
- Daire Farrell
- Address
- 3200 Lakeside Dr. Santa Clara CA US 95054 95054
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
- 3019677404
- 1000121056
- 3014222368
- 3008361782
- 1220452
- 2011171
- 3015190176
- 1219930
- 2528981
- 3022627847
- 1016427
- 1646831
- 3012050423
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 |
|---|---|---|---|
| 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 |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | C.R. Bard, Inc. | 2023-01-20 |