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LightningWire 01-180

by ElectroWire Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012834600 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LightningWire
Generic Name
Cardiac transseptal access electrosurgical catheter, single-use
Model / Ref / Catalog
01-180
Primary DI / UDI-DI
00860012834600
510(k) Number
FDA Product Code
DXF
GMDN Term
Cardiac transseptal access electrosurgical catheter, single-use
Device Class
Class II
Regulation Number
870.5175
GUDID distribution status
In Commercial Distribution
Size
Length — 180 Centimeter

Related devices

Cleared under the same submission (K261745)

Other devices from ElectroWire Corporation

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No