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/productcode/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 889)

Showing 20 most recent of 889 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260289](/device/K260289.md) | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | Jun 5, 2026 | SESE |
| [K260993](/device/K260993.md) | Amplatzer TorqVue Delivery System | Abbott | Apr 24, 2026 | SESE |
| [K253361](/device/K253361.md) | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Apr 10, 2026 | SESE |
| [K260499](/device/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](/device/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](/device/K252417.md) | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | Dec 17, 2025 | SESE |
| [K252390](/device/K252390.md) | Telescope Guide Extension Catheter | Medtronic, Ireland | Oct 29, 2025 | SESE |
| [K251277](/device/K251277.md) | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | Aug 22, 2025 | SESE |
| [K250147](/device/K250147.md) | CPS Locator 3D Delivery Catheter | Centerpoint Systems | Aug 22, 2025 | SESE |
| [K250972](/device/K250972.md) | Primum Hydrophilic Guiding Catheter | Pendracare | Jun 29, 2025 | SESE |
| [K250828](/device/K250828.md) | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Jun 27, 2025 | SESE |
| [K243184](/device/K243184.md) | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | Jun 25, 2025 | SESE |
| [K250492](/device/K250492.md) | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | Jun 18, 2025 | SESE |
| [K250219](/device/K250219.md) | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | Jun 17, 2025 | SESE |
| [K250410](/device/K250410.md) | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | Jun 2, 2025 | SESE |
| [K243757](/device/K243757.md) | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | May 2, 2025 | SESE |
| [K251014](/device/K251014.md) | APRO 45 Catheter | Alembic, LLC | May 1, 2025 | SESE |
| [K250962](/device/K250962.md) | APRO 55 Intermediate Catheter | Alembic, LLC | Apr 29, 2025 | SESE |
| [K250426](/device/K250426.md) | Amulet™ Steerable Delivery Sheath | ABBOTT MEDICAL | Apr 25, 2025 | SESE |
| [K242337](/device/K242337.md) | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | Apr 17, 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/productcode/DQY](https://fda.innolitics.com/productcode/DQY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com