Catalog Number

500-514

Brand Name

CavaClear

Version/Model Number

500-514

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DEN210024

Product Code

QRJ

Product Code Name

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

Public Device Record Key

96ca2043-59d5-4132-8acc-ef736f504d45

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-