Cleared Traditional

LightningWire Transseptal Puncture System (TPS) (K261745) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K261745 · ElectroWire Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
30d
Days
Class 2
Risk

K261745 is an FDA 510(k) clearance for the LightningWire Transseptal Puncture System (TPS). Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by ElectroWire Medical (Lexington, US). The FDA issued a Cleared decision on June 26, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ElectroWire Medical devices

Submission Details

510(k) Number K261745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2026
Decision Date June 26, 2026
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXF Catheter, Septostomy

All 13
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K261745.
SafeSept RF Transseptal Guidewire (SSRF132
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HOTWIRE RF GUIDEWIRE (901XXX)
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CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007 · Circa Scientific, Inc. · May 2025
Cross Wise™ Multi-Use RF Adapter Cable
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VersaCross™ RF Wire
K242076 · Baylis Medical Company · Nov 2024