DRE — Dilator, Vessel, For Percutaneous Catheterization Class II
FDA Device Classification
Classification Details
- Product Code
- DRE
- Device Class
- Class II
- Regulation Number
- 870.1310
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253616 | sorin group italia | ProtekDilate Vascular Access Kit | December 19, 2025 |
| K251325 | baylis medical company | VersaCross Connect Transseptal Dilator | May 29, 2025 |
| K242229 | merit medical systems | Micro Ace Gold Advanced Micro Access System | January 15, 2025 |
| K241720 | baylis medical company | VersaCross Connect Transseptal Dilator | July 12, 2024 |
| K233647 | baylis medical company | VersaCross Connect Transseptal Dilator | December 14, 2023 |
| K232609 | merit medical systems | Micro Ace Advanced Micro Access System | September 27, 2023 |
| K223472 | spectranetics | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard | December 15, 2022 |
| K212784 | spectranetics | TightRail Guardian Motorized Dilator Sheath | August 24, 2022 |
| K211679 | xcardia innovation | Xtractor device | February 17, 2022 |
| K210734 | cook incorporated | Endovascular Dilator and Sets | April 6, 2021 |
| K201288 | baylis medical company | ExpanSure Large Access Transseptal Dilator | June 12, 2020 |
| K192283 | medron | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - | May 6, 2020 |
| K200379 | togo medikit co | Super Sheath | March 19, 2020 |
| K192195 | galt medical | Sterile Dilator | September 26, 2019 |
| K190175 | merit medical systems | S-MAK XL | April 10, 2019 |
| K182064 | baylis medical company | ExpanSure Transseptal Dilation System | March 21, 2019 |
| K183036 | cook incorporated | Dilator Sets | December 20, 2018 |
| K182914 | mc3 incorporated | MC3 Vascular Access Kit 21030 | October 29, 2018 |
| K172487 | galt medical | Coaxial Dilator Set (Micro-Introducer) | October 16, 2017 |
| K162389 | medcomp ( medical components) | Medcomp Vessel Dilator | June 1, 2017 |