LightningWire Transseptal Puncture System (TPS)— 510(k) K261745
Substantially EquivalentElectroWire Medical
FDA 510(k) clearance K261745 for LightningWire Transseptal Puncture System (TPS), Substantially Equivalent on 2026-06-26. Applicant: ElectroWire Medical. Device class: 2.
Summary
ElectroWire Medical's LightningWire Transseptal Puncture System (TPS) is filed under DXF, septostomy catheters. The record doesn't list components or model numbers.
Class II, 21 CFR 870.5175. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
ElectroWire filed from Lexington, South Carolina. The decision came 30 calendar days after receipt (May 27 to June 26, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- ElectroWire Medical
- Product code
- Product code DXF
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, SC, US
Recent devices under product code DXF
view all- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- K243193 — Cross Wise Multi-Use RF Adapter Cable
Adverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.