Catalog Number

825-0101

Brand Name

Mikro-Cath Pressure Catheter

Version/Model Number

825-0101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K093111

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

2a5b4aff-2b15-48ba-96d1-97e4d9830d8e

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-