Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1310](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1310) → DRE — Dilator, Vessel, For Percutaneous Catheterization

# DRE · Dilator, Vessel, For Percutaneous Catheterization

_Cardiovascular · 21 CFR 870.1310 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DRE

## Overview

- **Product Code:** DRE
- **Device Name:** Dilator, Vessel, For Percutaneous Catheterization
- **Regulation:** [21 CFR 870.1310](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1310)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 104)

Showing 20 most recent of 104 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253616](/device/K253616.md) | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | Dec 19, 2025 | SESE |
| [K251325](/device/K251325.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | May 29, 2025 | SESE |
| [K242229](/device/K242229.md) | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | Jan 15, 2025 | SESE |
| [K241720](/device/K241720.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | Jul 12, 2024 | SESE |
| [K233647](/device/K233647.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | Dec 14, 2023 | SESE |
| [K232609](/device/K232609.md) | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | Sep 27, 2023 | SESE |
| [K223472](/device/K223472.md) | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | Spectranetics, Inc. | Dec 15, 2022 | SESE |
| [K212784](/device/K212784.md) | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | Aug 24, 2022 | SESE |
| [K211679](/device/K211679.md) | Xtractor device | Xcardia Innovation , Ltd. | Feb 17, 2022 | SESE |
| [K210734](/device/K210734.md) | Endovascular Dilator and Sets | Cook Incorporated | Apr 6, 2021 | SESE |
| [K201288](/device/K201288.md) | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | Jun 12, 2020 | SESE |
| [K192283](/device/K192283.md) | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | May 6, 2020 | SESE |
| [K200379](/device/K200379.md) | Super Sheath | Togo Medikit Co., Ltd. | Mar 19, 2020 | SESE |
| [K192195](/device/K192195.md) | Sterile Dilator | Galt Medical Corp. | Sep 26, 2019 | SESE |
| [K190175](/device/K190175.md) | S-MAK XL | Merit Medical Systems, Inc. | Apr 10, 2019 | SESE |
| [K182064](/device/K182064.md) | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | Mar 21, 2019 | SESE |
| [K183036](/device/K183036.md) | Dilator Sets | Cook Incorporated | Dec 20, 2018 | SESE |
| [K182914](/device/K182914.md) | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | Oct 29, 2018 | SESE |
| [K172487](/device/K172487.md) | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | Oct 16, 2017 | SESK |
| [K162389](/device/K162389.md) | Medcomp Vessel Dilator | Medcomp ( Medical Components) | Jun 1, 2017 | SESE |

## Top Applicants

- Merit Medical Systems, Inc. — 9 clearances
- Spectranetics, Inc. — 6 clearances
- Baylis Medical Company, Inc. — 5 clearances
- Cook Vascular, Inc. — 4 clearances
- Cook Incorporated — 3 clearances

---

**Source:** [https://fda.innolitics.com/productcode/DRE](https://fda.innolitics.com/productcode/DRE)

**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