Catalog Number

-

Brand Name

Refinity Rotational Intravascular Ultrasound IVUS Catheter

Version/Model Number

89800

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"

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

K160583

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

404a6c2c-94f0-4fb1-8a02-1a13eff0ca24

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-