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Stellarex 0.035" OTW drug-coated angioplasty balloon AB35SX050150080

by Philips Image Guided Therapy 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 Number00810060550250 UDI-DI Date30 Dec 2022ListedStatusListed 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  • Withdrawn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
Stellarex 0.035" OTW drug-coated angioplasty balloon
Generic Name
Peripheral angioplasty balloon catheter, drug-coated
Model / Ref / Catalog
AB35SX050150080
Primary DI / UDI-DI
00810060550250
PMA Number
FDA Product Code
ONU
GMDN Term
Peripheral angioplasty balloon catheter, drug-coated
Device Class
Class III
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 5 Millimeter
Balloon Length — 150 Millimeter
Catheter Length — 80 Centimeter

Related devices

Category: Peripheral angioplasty balloon catheter, drug-coated

Cleared under the same submission (P160049)

Show all (12)

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Properties

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

Other properties (7)

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