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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Septostomy
510(k) Number K261745
Device Name LightningWire Transseptal Puncture System (TPS)
Applicant
ElectroWire Medical
143 Industrial Dr.
Lexington,  SC  29072
Applicant Contact Robert (Bobby) Leonardi
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5175
Classification Product Code
DXF  
Date Received05/27/2026
Decision Date 06/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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