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Empower™ Introducer Sheath With Hydrophilic Coating

FDA UDI

Class II (US FDA UDI)

by Freudenberg Medical, Llc

Identity

Trade Name
EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING FDA UDI
Generic Name
Vascular dilator, single-use FDA UDI
Device Name
The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist. FDA UDI
Model / Reference
668782-100 FDA UDI
Description
The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist. FDA UDI

Identifiers

Catalog Number
PN1007960-100 FDA UDI
Primary DI / UDI-DI
00850004312001 FDA UDI
510(k) Number
K190628 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 21 French FDA UDI
Catheter Working Length — 56 Centimeter FDA UDI
Guidewire Diameter — .035 Inch FDA UDI
Lumen/Inner Diameter — 7.0 Millimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantableVascular guide-catheter, single-useVascular dilator, single-useHaemostasis valve

Empower™ Introducer Sheath With Hydrophilic Coating by Freudenberg Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemostasis valve.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Freudenberg Medical, Llc

Sources (1)

  • FDA UDI ec03b20e-6c7e-4abb-a2bc-86f5a1d7987a 38 fields · synced Sep 18, 2026