Catalog Number

-

Brand Name

MITCHELL AORTIC VALVE DILATOR

Version/Model Number

2700-219

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 02, 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

-

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

K100518

Product Code

DWP

Product Code Name

Dilator, Vessel, Surgical

Public Device Record Key

9383a67d-cd25-4010-83db-493bedf38a7f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-