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LUTONIX® Drug Coated Balloon LX351307100

by Lutonix, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741088698 UDI-DI Date10 Sep 2018ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LUTONIX® Drug Coated Balloon
Generic Name
Peripheral angioplasty balloon catheter, drug-coated
Model / Ref / Catalog
LX351307100
Primary DI / UDI-DI
00801741088698
FDA Product Code
ONU
GMDN Term
Peripheral angioplasty balloon catheter, drug-coated
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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