Total clearances
10
2020-06-12 → 2025-05-29
Name variants in FDA filings: Baylis Medical Company / Baylis Medical Company, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| DRE |
Dilator, Vessel, For Percutaneous Catheterization |
Class II |
Cardiovascular |
4 |
2025-05-29 |
| DYB |
Introducer, Catheter |
Class II |
Cardiovascular |
3 |
2023-12-20 |
| DQX |
Wire, Guide, Catheter |
Class II |
Cardiovascular |
2 |
2023-03-01 |
| DXF |
— |
— |
— |
1 |
2024-11-01 |
Filings
All 510(k) clearances (10)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-05-29 |
K251325 |
VersaCross Connect Transseptal Dilator |
DRE |
Class II |
Cardiovascular |
| 2024-11-01 |
K242076 |
VersaCross RF Wire |
DXF |
— |
— |
| 2024-07-12 |
K241720 |
VersaCross Connect Transseptal Dilator |
DRE |
Class II |
Cardiovascular |
| 2023-12-20 |
K231227 |
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2023-12-14 |
K233647 |
VersaCross Connect Transseptal Dilator |
DRE |
Class II |
Cardiovascular |
| 2023-03-01 |
K213898 |
ProTrack Pigtail Wire |
DQX |
Class II |
Cardiovascular |
| 2022-12-19 |
K221351 |
Mechanical Guidewire |
DQX |
Class II |
Cardiovascular |
| 2022-06-30 |
K213582 |
Epicardial Access System |
DYB |
Class II |
Cardiovascular |
| 2022-05-09 |
K220414 |
VersaCross Connect Transseptal Dilator |
DYB |
Class II |
Cardiovascular |
| 2020-06-12 |
K201288 |
ExpanSure Large Access Transseptal Dilator |
DRE |
Class II |
Cardiovascular |