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 |
|---|---|---|---|
| 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 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 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 |
| K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | 2025-01-15 |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 |
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) | ABBOTT MEDICAL | 2024-12-31 |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | 2024-12-20 |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | 2024-12-19 |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2024-12-04 |
| K242276 | CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | 2024-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842429106563 | Balloon Catheter | Microvention, Inc. | 2022-06-14 |
| 00763000270773 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270711 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270544 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270520 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270384 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270360 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270346 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-08 |
| 00763000270308 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270759 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270735 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270698 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270674 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270650 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270612 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270599 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270575 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270797 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270223 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270506 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270483 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270421 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270407 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270247 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00763000270322 | Solitaire™ X-PACK | Micro Therapeutics, Inc. | 2019-11-07 |
| 00847536003552 | ReverseTM | Reverse Medical Corporation | 2016-08-19 |
| 00847536003569 | ReverseTM | Reverse Medical Corporation | 2016-08-12 |
| 00643169530102 | ATTAIN CLARITY™ | MEDTRONIC, INC. | 2016-07-16 |
| 00613994746610 | ATTAIN SELECT™ II | MEDTRONIC, INC. | 2016-07-16 |
| 00613994746801 | ATTAIN SELECT™ II | MEDTRONIC, INC. | 2016-04-11 |