Skip to content

transGlide Expandable Introducer 16F transGlide Expandable Introducer

by Transaortic Medical, Inc.

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 Number00866697000200 UDI-DI Date1 Sep 2016ListedStatusListed 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  • Withdrawn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
transGlide Expandable Introducer
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
16F transGlide Expandable Introducer, TA-004
Primary DI / UDI-DI
00866697000200
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 5.3 Millimeter

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K152194)

Other devices from Transaortic Medical, Inc.

Properties

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

Other properties (9)

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