Catalog Number

393305

Brand Name

Pantera Pro

Version/Model Number

1.25/20/140

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

K160985

Product Code

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Public Device Record Key

0cd44fe3-10ef-4918-976d-bcfd8dcdcacb

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

November 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-