← Back to catalogue

Venos Occlusion Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Oscor Inc.

Identity

Trade Name
Venos Occlusion Balloon Catheter FDA UDI
Generic Name
Cardiac sizing catheter FDA UDI
Device Name
Occlusion Balloon Catheter, 6F FDA UDI
Model / Reference
V0610010 FDA UDI
Description
Occlusion Balloon Catheter, 6F FDA UDI

Identifiers

Catalog Number
V0610010 FDA UDI
Primary DI / UDI-DI
00836559006930 FDA UDI
510(k) Number
K081052 FDA UDI
FDA Product Code
DYG FDA UDI
GMDN Term
Cardiac sizing catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1240 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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 100 Centimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

Category: Cardiac sizing catheter

Venos Occlusion Balloon Catheter by Oscor Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac sizing catheter.

Cleared under the same submission

K081052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Oscor Inc.

Sources (1)

  • FDA UDI e5cc6eed-04f7-42db-a6fc-64fc9aede535 38 fields · synced May 30, 2026