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Volare Microcatheter VLRE26F160

by Balt USA LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00840303714200 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Volare Microcatheter
Generic Name
Vascular microcatheter
Model / Ref / Catalog
VLRE26F160
Primary DI / UDI-DI
00840303714200
510(k) Number
FDA Product Code
DQY, QJP, KRA
GMDN Term
Vascular microcatheter
Device Class
Class II
Regulation Number
870.1250, 870.1210
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K260199)

Other devices from Balt USA LLC

See all devices from Balt USA LLC →

Properties

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

Other properties (8)

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