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Ventricular vent catheter

FDA UDI

Class II (US FDA UDI)

by LivaNova USA, Inc.

Identity

Trade Name
Ventricular vent catheter FDA UDI
Generic Name
Heart ventricle cannula FDA UDI
Model / Reference
VT-xxxxx FDA UDI

Identifiers

Primary DI / UDI-DI
00803622106484 FDA UDI
510(k) Number
K981601 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Heart ventricle cannula FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 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
MRI Safety
MR Unsafe FDA UDI

Category: Heart ventricle cannula

Ventricular vent catheter by LivaNova USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heart ventricle cannula.

Cleared under the same submission

K981601 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LivaNova USA, Inc.

Sources (1)

  • FDA UDI f1021c9e-327f-420c-b94f-fba5e0386662 33 fields · synced Jun 8, 2026