Catalog Number

MGC39140A

Brand Name

ELITECROSS Support Catheter

Version/Model Number

MGC39140A

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

K150187

Product Code

PDU

Product Code Name

Catheter for crossing total occlusions

Public Device Record Key

13dd3adb-5414-40cc-8201-e2166181bbb5

Public Version Date

September 14, 2022

Public Version Number

10

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-