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WavelinQ FX-001CE

by Tva Medical, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868260000211 UDI-DI Date27 Aug 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  • Withdrawn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
WavelinQ
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
FX-001CE
Primary DI / UDI-DI
00868260000211
FDA Product Code
PQK
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1252
GUDID distribution status
Not in Commercial Distribution
Size
Catheter Gauge — 6 French

Other devices from Tva Medical, Inc.

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