Cleared Traditional

K261745 - LightningWire Transseptal Puncture System (TPS)

K261745 is an FDA 510(k) clearance for LightningWire Transseptal Puncture Syst..., manufactured by ElectroWire Medical. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K261745 · ElectroWire Medical · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K261745

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
Combination Product No
PCCP Authorized No
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.

DXF Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXF Catheter, Septostomy

All 20
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K261745.
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