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VARIPULSE™ Bi-Directional Catheter

FDA UDI

Class III (US FDA UDI)

by Biosense Webster Inc

Identity

Trade Name
VARIPULSE™ Bi-Directional Catheter FDA UDI
Generic Name
Cardiac irreversible electroporation system catheter FDA UDI
Device Name
8.5 FR VARIPULSE™ Bi-Directional Catheter FDA UDI
Model / Reference
D141201 FDA UDI
Description
8.5 FR VARIPULSE™ Bi-Directional Catheter FDA UDI

Identifiers

Catalog Number
D141201 FDA UDI
Primary DI / UDI-DI
10846835025460 FDA UDI
PMA Number
P240006 FDA UDI
FDA Product Code
QZI FDA UDI
GMDN Term
Cardiac irreversible electroporation system catheter FDA UDI

Classification

Device Class
Class III 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: Cardiac irreversible electroporation system catheter

VARIPULSE™ Bi-Directional Catheter by Biosense Webster Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac irreversible electroporation system catheter.

Cleared under the same submission

P240006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biosense Webster Inc

Sources (1)

  • FDA UDI 6d85d7a0-1566-4fc3-bdf7-f93b9dc6d1f6 37 fields · synced May 30, 2026