Product code DQY
- Device name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | 2026-09-18 |
| K260559 | NHanceIT | IMDS Operation B.V. | 2026-08-14 |
| K262392 | APRO 35 Swift Catheter | Alembic, LLC | 2026-08-12 |
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | 2026-03-13 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 |
| K251014 | APRO 45 Catheter | Alembic, LLC | 2025-05-01 |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 2025-04-29 |
| K250426 | Amulet™ Steerable Delivery Sheath | ABBOTT MEDICAL | 2025-04-25 |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | 2025-04-17 |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | 2025-04-04 |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | 2025-03-27 |
| K243436 | Seclusion Catheter | Basis Medical | 2025-02-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00802526625008 | ACUITY™ | BOSTON SCIENTIFIC CORPORATION | 2026-10-15 |
| 00857545008431 | Zebra | Q'APEL MEDICAL LLC | 2026-03-05 |
| 00857545008400 | Zebra | Q'APEL MEDICAL LLC | 2026-03-05 |
| 00857545008394 | Zebra | Q'APEL MEDICAL LLC | 2026-03-05 |
| 00843152100057 | IOPS Visionary System | Centerline Biomedical, Inc. | 2026-02-24 |
| 00857545008288 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008271 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008264 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008257 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008240 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008233 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008226 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008158 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008165 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008172 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008189 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008196 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008202 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 00857545008219 | Zebra | Q'APEL MEDICAL LLC | 2025-01-03 |
| 05415067032287 | Agilis HisPro™ | ST. JUDE MEDICAL, INC. | 2020-06-18 |
| 00853892004058 | Boosting Catheter | QXMEDICAL | 2018-07-11 |
| 00853892004041 | Boosting Catheter | QXMEDICAL | 2018-07-11 |
| 00821329000669 | Boston Scientific Channel Steerable Sheath | Greatbatch Ltd | 2018-02-06 |
| 00821329000652 | Boston Scientific Channel Steerable Sheath | Greatbatch Ltd | 2018-02-06 |
| 00821329000423 | Greatbatch Steerable Sheath | Greatbatch Ltd | 2017-10-19 |
| 00821329000416 | Greatbatch Steerable Sheath | Greatbatch Ltd | 2017-10-19 |
| 00853892004034 | Boosting Catheter | QXMEDICAL | 2017-01-06 |
| 00853892004027 | Boosting Catheter | QXMEDICAL | 2016-11-23 |
| 00821329601507 | Greatbatch Steerable Sheath | Greatbatch Ltd | 2016-09-24 |
| 00821329601491 | Greatbatch Steerable Sheath | Greatbatch Ltd | 2016-09-24 |