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/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K253616.md) | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | Dec 19, 2025 | SESE | | [K251325](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K251325.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | May 29, 2025 | SESE | | [K242229](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K242229.md) | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | Jan 15, 2025 | SESE | | [K241720](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K241720.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | Jul 12, 2024 | SESE | | [K233647](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K233647.md) | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | Dec 14, 2023 | SESE | | [K232609](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K232609.md) | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | Sep 27, 2023 | SESE | | [K223472](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K212784.md) | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | Aug 24, 2022 | SESE | | [K211679](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K211679.md) | Xtractor device | Xcardia Innovation , Ltd. | Feb 17, 2022 | SESE | | [K210734](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K210734.md) | Endovascular Dilator and Sets | Cook Incorporated | Apr 6, 2021 | SESE | | [K201288](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K201288.md) | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | Jun 12, 2020 | SESE | | [K192283](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K200379.md) | Super Sheath | Togo Medikit Co., Ltd. | Mar 19, 2020 | SESE | | [K192195](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K192195.md) | Sterile Dilator | Galt Medical Corp. | Sep 26, 2019 | SESE | | [K190175](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K190175.md) | S-MAK XL | Merit Medical Systems, Inc. | Apr 10, 2019 | SESE | | [K182064](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K182064.md) | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | Mar 21, 2019 | SESE | | [K183036](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K183036.md) | Dilator Sets | Cook Incorporated | Dec 20, 2018 | SESE | | [K182914](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K182914.md) | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | Oct 29, 2018 | SESE | | [K172487](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K172487.md) | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | Oct 16, 2017 | SESK | | [K162389](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/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/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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