Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → DQY — Catheter, Percutaneous # DQY · Catheter, Percutaneous _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY ## Overview - **Product Code:** DQY - **Device Name:** Catheter, Percutaneous - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K253361.md) | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Apr 10, 2026 | SESE | | [K260499](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K260499.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K253409.md) | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | Dec 19, 2025 | SESE | | [K252417](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K252417.md) | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | Dec 17, 2025 | SESE | | [K252390](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K252390.md) | Telescope Guide Extension Catheter | Medtronic, Ireland | Oct 29, 2025 | SESE | | [K251277](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K251277.md) | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | Aug 22, 2025 | SESE | | [K250147](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250147.md) | CPS Locator 3D Delivery Catheter | Centerpoint Systems | Aug 22, 2025 | SESE | | [K250972](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250972.md) | Primum Hydrophilic Guiding Catheter | Pendracare | Jun 29, 2025 | SESE | | [K250828](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250828.md) | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Jun 27, 2025 | SESE | | [K243184](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K243184.md) | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | Jun 25, 2025 | SESE | | [K250492](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250492.md) | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | Jun 18, 2025 | SESE | | [K250219](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250219.md) | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | Jun 17, 2025 | SESE | | [K250410](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250410.md) | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | Jun 2, 2025 | SESE | | [K243757](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K243757.md) | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | May 2, 2025 | SESE | | [K251014](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K251014.md) | APRO 45 Catheter | Alembic, LLC | May 1, 2025 | SESE | | [K250962](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250962.md) | APRO 55 Intermediate Catheter | Alembic, LLC | Apr 29, 2025 | SESE | | [K250426](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250426.md) | Amulet™ Steerable Delivery Sheath | ABBOTT MEDICAL | Apr 25, 2025 | SESE | | [K242337](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K242337.md) | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | Apr 17, 2025 | SESE | | [K243691](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K243691.md) | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | Apr 4, 2025 | SESE | | [K250558](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K250558.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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