Catalog Number

5010028

Brand Name

VENA TECH

Version/Model Number

5010028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152765

Product Code

DTK

Product Code Name

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Public Device Record Key

c60c93c2-b64d-4b20-b596-24b1e8740e33

Public Version Date

March 30, 2021

Public Version Number

8

DI Record Publish Date

March 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-