Enteer™

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name: Enteer™ FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: CATH ENB-275-20-150 CTO RE-ENTRY V03 FDA UDI
Model / Reference: ENB-275-20-150 FDA UDI
Description: CATH ENB-275-20-150 CTO RE-ENTRY V03 FDA UDI

Identifiers

Primary DI / UDI-DI: 00821684073780 FDA UDI
510(k) Number: K120129 FDA UDI
K120533 FDA UDI
FDA Product Code: PDU FDA UDI
GMDN Term: Vascular guide-catheter, single-use 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

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 150.0 Centimeter FDA UDI
Catheter Gauge — 5.0 French FDA UDI

Category: Vascular guide-catheter, single-use

Enteer™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Zebra — QApel Medical, Inc. · Class II
Mach1™ — Boston Scientific · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II

Cleared under the same submission

K120129 also covers:

Enteer™ — EV3, INC

K120533 also covers:

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: Ev3, Inc

Sources (1)

FDA UDI b8898b6a-026d-4b0d-8e5e-6f8ba99ed699 37 fields · synced May 31, 2026