EMBA Hourglass Peripheral Embolization Device

FDA UDI

Class II (US FDA UDI)

by Embolic Acceleration, LLC

Identity

Trade Name: EMBA Hourglass Peripheral Embolization Device FDA UDI
Generic Name: Non-neurovascular embolization plug, metallic FDA UDI
Model / Reference: PEP-001-US FDA UDI

Identifiers

Primary DI / UDI-DI: 00860002787107 FDA UDI
510(k) Number: K171845 FDA UDI
FDA Product Code: KRD FDA UDI
GMDN Term: Non-neurovascular embolization plug, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Non-neurovascular embolization plug, metallic

EMBA Hourglass Peripheral Embolization Device by Embolic Acceleration, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-neurovascular embolization plug, metallic.

Solus Gold™ Embolization Device — Artio Medical, Inc. · Class II
HARBOR — Nuvascular, Inc. · Class II
Micro Plug Set — Ka Medical, LLC · Class II
Amplatzer™ — Aga Medical Corp. · Class II
LOBO — Okami Medical Inc. · Class II
Solus Gold™ Embolization Device — Artio Medical, Inc. · Class II
AMPLATZER™ — Aga Medical Corp. · Class II
Amplatzer™ — Aga Medical Corp. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Embolic Acceleration, LLC

Sources (1)

FDA UDI 0a17a2e3-ed5b-4e49-b434-f2a6ca921225 33 fields · synced May 29, 2026