Catalog Number

367045

Brand Name

Pantera LEO

Version/Model Number

5.0/30/145

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

K163660

Product Code

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Public Device Record Key

7ebf3859-d86d-402f-ae40-8425adc3e8ff

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

February 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-