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Soft-Vu

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
Soft-Vu FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
Soft-Vu Angiographic Catheter, Omni Flush Mini, Non-Braided FDA UDI
Model / Reference
10732304 FDA UDI
Description
Soft-Vu Angiographic Catheter, Omni Flush Mini, Non-Braided FDA UDI

Identifiers

Primary DI / UDI-DI
H787107323040 FDA UDI
510(k) Number
K112452 FDA UDI
K161596 FDA UDI
K173762 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Angiographic catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Dimensions & Sizes

Size
Pressure — 1050 Pound per Square Inch FDA UDI
Catheter Gauge — 4 French FDA UDI
Length — 65 Centimeter FDA UDI
Outer Diameter — 1.4 Millimeter FDA UDI

Category: Angiographic catheter, single-use

Soft-Vu by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

Cleared under the same submission

K112452 also covers:

K161596 also covers:

K173762 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI 13997082-3c2d-4d41-b41c-5c05dec8a408 37 fields · synced Jun 8, 2026