Baylis Medical Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K254114 | Baylis Connector Cable | January 18, 2026 |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | October 28, 2025 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | September 11, 2025 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | February 28, 2024 |
| K230571 | RFP-100A Connector Cable (Single Use) | May 30, 2023 |