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SELUTION SLR™ 014 PTCA Drug-Eluting Balloon SCB14U-300025D

by Medalliance, LLC

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 Number00810220870266 UDI-DI Date21 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  • Withdrawn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
SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
Generic Name
Coronary angioplasty balloon catheter, drug-coated
Model / Reference
SCB14U-300025D
Primary DI / UDI-DI
00810220870266
PMA Number
FDA Product Code
OOB
GMDN Term
Coronary angioplasty balloon catheter, drug-coated
Device Class
Class III
GUDID distribution status
In Commercial Distribution
Size
Balloon Diameter — 3.00 Millimeter
Balloon Length — 25 Millimeter

Related devices

Cleared under the same submission (P250041)

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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