Catalog Number

-

Brand Name

ClearLumen II Peripheral Catheter

Version/Model Number

WV0613507-04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2018

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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"

-

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

-

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

30f9ccf9-8167-4c50-a5aa-57f7f013ebb4

Public Version Date

September 27, 2022

Public Version Number

5

DI Record Publish Date

January 24, 2018

Package DI Number

B139WV0613507041

Quantity per Package

1

Contains DI Package

B139WV0613507040

Package Discontinue Date

February 21, 2018

Package Status

Not in Commercial Distribution

Package Type

Carton Box