DRE · Dilator, Vessel, For Percutaneous Catheterization
Cardiovascular · 21 CFR 870.1310 · Class 2
Overview
| Product Code | DRE |
|---|---|
| Device Name | Dilator, Vessel, For Percutaneous Catheterization |
| Regulation | 21 CFR 870.1310 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | Dec 19, 2025 | SESE |
| K251325 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | May 29, 2025 | SESE |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | Jan 15, 2025 | SESE |
| K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | Jul 12, 2024 | SESE |
| K233647 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | Dec 14, 2023 | SESE |
| K232609 | Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. | Sep 27, 2023 | SESE |
| K223472 | 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 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | Aug 24, 2022 | SESE |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | Feb 17, 2022 | SESE |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | Apr 6, 2021 | SESE |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | Jun 12, 2020 | SESE |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | May 6, 2020 | SESE |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | Mar 19, 2020 | SESE |
| K192195 | Sterile Dilator | Galt Medical Corp. | Sep 26, 2019 | SESE |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | Apr 10, 2019 | SESE |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | Mar 21, 2019 | SESE |
| K183036 | Dilator Sets | Cook Incorporated | Dec 20, 2018 | SESE |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | Oct 29, 2018 | SESE |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | Oct 16, 2017 | SESK |
| K162389 | 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
