510(k) K251158
K251158 is an FDA 510(k) premarket notification submitted by Baylis Medical Technologies, Inc. for the device "PowerWire® 14 Radiofrequency Guidewire Kit". The FDA issued a decision of Substantially Equivalent (kit) on September 11, 2025. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Baylis Medical Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- September 11, 2025
- Date Received
- April 15, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter For Crossing Total Occlusions
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.