FDA 510(k)

LightningWire Transseptal Puncture System (TPS)

Número K: K261745 · 2026-06-26

Data da decisão2026-06-26

Código do produtoDXF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

LightningWire Transseptal Puncture System (TPS) is the device name listed in this FDA 510(k) record. The listed applicant is ElectroWire Medical. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K261745. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LightningWire Transseptal Puncture System (TPS)?

LightningWire Transseptal Puncture System (TPS) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is ElectroWire Medical. The 510(k) number is K261745.

When did LightningWire Transseptal Puncture System (TPS) receive FDA 510(k) clearance?

LightningWire Transseptal Puncture System (TPS) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K261745.

Who is the listed applicant for LightningWire Transseptal Puncture System (TPS)?

The FDA 510(k) record lists ElectroWire Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightningWire Transseptal Puncture System (TPS)?

The FDA product code for LightningWire Transseptal Puncture System (TPS) is DXF.

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Fonte oficial

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