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Vizigo

FDA UDI

Class II (US FDA UDI)

by Biosense Webster Inc

Identity

Trade Name
VIZIGO FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Model / Reference
D138503 FDA UDI

Identifiers

Catalog Number
D138503 FDA UDI
Primary DI / UDI-DI
10846835016260 FDA UDI
510(k) Number
K170997 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Category: Vascular catheter introduction set, nonimplantable

Vizigo by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Cleared under the same submission

K170997 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 a0ea17bc-f957-4851-841c-0aa3767d281f 34 fields · synced May 30, 2026