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FDA 510(k)

LightningWire Transseptal Puncture System (TPS)

K-Number: K261745 · 2026-06-26

ApplicantElectroWire Medical
Decision Date2026-06-26
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: DXF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.K242076VersaCross™ RF WireBaylis Medical Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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