DRE
- Product code
- DRE
- Device name
- Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1310
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 105 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261310 | 2026-07-27 | Merit Medical Systems, Inc. | FlexTract Deflectable-Rotational Dilator Sheath Set | |
| K253616 | 2025-12-19 | Sorin Group Italia S.R.L. | ProtekDilate Vascular Access Kit | |
| K251325 | 2025-05-29 | Baylis Medical Company, Inc. | VersaCross Connect Transseptal Dilator | |
| K242229 | 2025-01-15 | Merit Medical Systems, Inc. | Micro Ace Gold Advanced Micro Access System | |
| K241720 | 2024-07-12 | Baylis Medical Company, Inc. | VersaCross Connect Transseptal Dilator | |
| K233647 | 2023-12-14 | Baylis Medical Company, Inc. | VersaCross Connect Transseptal Dilator | |
| K232609 | 2023-09-27 | Merit Medical Systems, Inc. | Micro Ace Advanced Micro Access System |
Official FDA classification page: DRE
Classification and pathway per current FDA publications. Data from openFDA (CC0).