FDA 510(k)
FDA class 2
Unknown
🇨🇦 Canada
PowerWire® 14 Radiofrequency Guidewire Kit
K Number: K251158
·
Decision Sep 11, 2025
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
5
Review Days
149
Basic Information
- Device Name
- PowerWire® 14 Radiofrequency Guidewire Kit
- K Number
- K251158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Baylis Medical Technologies, Inc.
- Date Received
- April 15, 2025
- Decision Date
- September 11, 2025
- Product Code
- PDU
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDU), ordered by most recent decision date.
Santreva-ATK Endovascular Revasculariztion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow ARC
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
SoundBite® Crossing System XS Peripheral
FDA 510(k)
FDA Class 2
·Cardiovascular
Tigereye ST CTO-Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Tunnel Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Baylis Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254114 | Baylis Connector Cable | Jan 18, 2026 | Substantially Equivalent |
| K250275 | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Oct 28, 2025 | Substantially Equivalent |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Feb 28, 2024 | Unknown |
| K230571 | RFP-100A Connector Cable (Single Use) | May 30, 2023 | Substantially Equivalent |