DQY · Catheter, Percutaneous
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | DQY |
|---|---|
| Device Name | Catheter, Percutaneous |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 887)
Showing 20 most recent of 887 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Apr 10, 2026 | SESE |
| 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 | Mar 13, 2026 | SESE |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | Dec 19, 2025 | SESE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | Dec 17, 2025 | SESE |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | Oct 29, 2025 | SESE |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | Aug 22, 2025 | SESE |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | Aug 22, 2025 | SESE |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | Jun 29, 2025 | SESE |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Jun 27, 2025 | SESE |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | Jun 25, 2025 | SESE |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | Jun 18, 2025 | SESE |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | Jun 17, 2025 | SESE |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | Jun 2, 2025 | SESE |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | May 2, 2025 | SESE |
| K251014 | APRO 45 Catheter | Alembic, LLC | May 1, 2025 | SESE |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | Apr 29, 2025 | SESE |
| K250426 | Amulet Steerable Delivery Sheath | ABBOTT MEDICAL | Apr 25, 2025 | SESE |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | Apr 17, 2025 | SESE |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | Apr 4, 2025 | SESE |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | Mar 27, 2025 | SESE |
Top Applicants
- Medtronic Vascular — 31 clearances
- Biotronik, Inc. — 23 clearances
- Cordis Corp. — 21 clearances
- Vascular Solutions, Inc. — 21 clearances
- Cook, Inc. — 20 clearances
