Embotrap

FDA UDI

Class II (US FDA UDI)

by Neuravi, Ltd.

Identity

Trade Name: EMBOTRAP FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: EMBOTRAP III 5 x 37 mm Revascularisation Device FDA UDI
Model / Reference: ET309537 FDA UDI
Description: EMBOTRAP III 5 x 37 mm Revascularisation Device FDA UDI

Identifiers

Catalog Number: ET309537 FDA UDI
Primary DI / UDI-DI: 10886704084570 FDA UDI
510(k) Number: K193063 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Category: Thrombectomy suction catheter

Embotrap by Neuravi, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Penumbra System — PENUMBRA, INC. · Class II
Trevo — Stryker Corp.
Penumbra System — PENUMBRA, INC. · Class II
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II

Cleared under the same submission

K193063 also covers:

EMBOTRAP — Neuravi, Ltd.

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: Neuravi, Ltd.

Sources (1)

FDA UDI c339635d-2753-4f09-a5b6-a1f27ead68c3 35 fields · synced May 31, 2026