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Paragon 8F Balloon Guide Cathete BG8F085

by Shanghai Wallaby Medical Technologies Co., Inc. 2 variants

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 Number06970908212079 UDI-DI Date15 Apr 2026ListedStatusListed 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  • Withdrawn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
Paragon 8F Balloon Guide Cathete
Generic Name
Intravascular occluding balloon catheter, image-guided
Model / Reference
BG8F085
Primary DI / UDI-DI
06970908212079
FDA Product Code
DQY, QJP
GMDN Term
Intravascular occluding balloon catheter, image-guided
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution

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Properties

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

Other properties (10)

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