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Empower™ Introducer Sheath with Hydrophilic Coating 668782-101

by Freudenberg Medical LLC United States GUDID

Product code DYB

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00198715836998 UDI-DIDate29 Jan 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1016-2022 FDA Class II initiated 21 Feb 2022
    • Terminated Z-1017-2022 FDA Class II initiated 21 Feb 2022

    Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

Specification

GUDID · synced 23 Oct 2026

Trade Name
Empower™ Introducer Sheath with Hydrophilic Coating
Generic Name
Vascular dilator, single-use
Model / Ref / Catalog
668782-101, PN1007960-100
Primary DI / UDI-DI
00198715836998
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular dilator, single-use
Device Class
Class II
Regulation Number
870.1340
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Catheter Gauge — 21 French
Catheter Working Length — 56 Centimeter
Guidewire Diameter — 0.035 Inch
Lumen/Inner Diameter — 7.0 Millimeter

Related devices

Cleared under the same submission (K190628)

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • FDA UDI 458d91bd-7677-4f65-a561-9c2d0ff796ba 38 fields · synced 23 Oct 2026