Baylis Medical Company, Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories7
Latest Approval2025-05-29
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251325 | VersaCross Connect Transseptal Dilator | DRE | 2025-05-29 | View |
| 510(k) | K241720 | VersaCross Connect Transseptal Dilator | DRE | 2024-07-12 | View |
| 510(k) | K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | DYB | 2023-12-20 | View |
| 510(k) | K233647 | VersaCross Connect Transseptal Dilator | DRE | 2023-12-14 | View |
| 510(k) | K213898 | ProTrack Pigtail Wire | DQX | 2023-03-01 | View |
| 510(k) | K221351 | Mechanical Guidewire | DQX | 2022-12-19 | View |
| 510(k) | K213582 | Epicardial Access System | DYB | 2022-06-30 | View |
| 510(k) | K220414 | VersaCross Connect Transseptal Dilator | DYB | 2022-05-09 | View |
| 510(k) | K201288 | ExpanSure Large Access Transseptal Dilator | DRE | 2020-06-12 | View |
| 510(k) | K191546 | Epicardial Access System | DYB | 2019-08-02 | View |
| 510(k) | K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | DRF | 2019-06-07 | View |
| 510(k) | K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | DRF | 2019-06-07 | View |
| 510(k) | K183655 | VersaCross Transseptal Sheath | DYB | 2019-05-20 | View |
| 510(k) | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | DYB | 2019-04-17 | View |
| 510(k) | K182064 | ExpanSure Transseptal Dilation System | DRE | 2019-03-21 | View |
| 510(k) | K181864 | Polaris RF Ablation System | GXD | 2019-01-02 | View |
| 510(k) | K161949 | OsteoCool V-3 RF Ablation System | GEI | 2017-01-31 | View |
| 510(k) | K161878 | PORTAGE System | HRX | 2016-09-26 | View |
No matching devices.