510(k) K261745
K261745 is an FDA 510(k) premarket notification submitted by ElectroWire Medical for the device "LightningWire Transseptal Puncture System (TPS)". The FDA issued a decision of Substantially Equivalent on June 26, 2026. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2026
- Date Received
- May 27, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Septostomy
- Device Class
- Class II
- Regulation Number
- 870.5175
- Review Panel
- CV
- Submission Type