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AngioVac

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name
AngioVac FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
Device Name
AngioVac C180 with Obturator FDA UDI
Model / Reference
H965251940 FDA UDI
Description
AngioVac C180 with Obturator FDA UDI

Identifiers

Catalog Number
25194 FDA UDI
Primary DI / UDI-DI
15051684016506 FDA UDI
510(k) Number
K190594 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage 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

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

AngioVac by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage.

Cleared under the same submission

K190594 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 b6d9b9f3-c78b-4b8b-8bc3-bb8c8e1a97dc 36 fields · synced Jun 20, 2026