DRE — Dilator, Vessel, For Percutaneous Catheterization Class II
FDA product code DRE covers "Dilator, Vessel, For Percutaneous Catheterization", a Class II medical device regulated under 21 CFR 870.1310. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |