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LUTONIX® Drug Coated Balloon LX1815051505F

by Lutonix, Inc.

Listed FDA GUDID listing, no authorization on record

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741199318 UDI-DI Date9 Sep 2019ListedStatusListed GUDID: 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  • Withdrawn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
LX1815051505F
Primary DI / UDI-DI
00801741199318
FDA Product Code
ONU, PRC
GMDN Term
Peripheral angioplasty balloon catheter, drug-coated
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peripheral angioplasty balloon catheter, drug-coated

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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