510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261745Substantially Equivalent

LightningWire Transseptal Puncture System (TPS)

ElectroWire Medical, Lexington SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261745 is the FDA 510(k) clearance record for LightningWire Transseptal Puncture System (TPS), a class II device, cleared for ElectroWire Medical on under FDA product code DXF (Catheter, Septostomy). FDA records list one 510(k) clearance for ElectroWire Medical. As of , FDA records show no recalls naming K261745.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
ElectroWire Medical 143 Industrial Dr., Lexington SC
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXF

Trailing 12 months
3 clearances under product code DXF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260