Baylis Medical Company Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2069-2020 | Class II | TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32 | October 7, 2019 |
| Z-2070-2020 | Class II | NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711 | October 7, 2019 |
| Z-0879-2013 | Class II | BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. | October 4, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251325 | VersaCross Connect Transseptal Dilator | May 29, 2025 |
| K241720 | VersaCross Connect Transseptal Dilator | July 12, 2024 |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | December 20, 2023 |
| K233647 | VersaCross Connect Transseptal Dilator | December 14, 2023 |
| K213898 | ProTrack Pigtail Wire | March 1, 2023 |
| K221351 | Mechanical Guidewire | December 19, 2022 |
| K213582 | Epicardial Access System | June 30, 2022 |
| K220414 | VersaCross Connect Transseptal Dilator | May 9, 2022 |
| K201288 | ExpanSure Large Access Transseptal Dilator | June 12, 2020 |
| K191546 | Epicardial Access System | August 2, 2019 |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | June 7, 2019 |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | June 7, 2019 |
| K183655 | VersaCross Transseptal Sheath | May 20, 2019 |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | April 17, 2019 |
| K182064 | ExpanSure Transseptal Dilation System | March 21, 2019 |
| K181864 | Polaris RF Ablation System | January 2, 2019 |
| K161949 | OsteoCool V-3 RF Ablation System | January 31, 2017 |
| K161878 | PORTAGE System | September 26, 2016 |
| K152057 | OsteoCool V-3 RF Ablation System | November 24, 2015 |
| K151009 | Nexus Suture | August 18, 2015 |