Catalog Number

-

Brand Name

Cronus™ HP - OTW PTA BALLOON CATHETER

Version/Model Number

NCH+93045

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 29, 2020

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

K151141

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

b9e2bb3a-4bda-4cda-a4cf-d0555cf7e70d

Public Version Date

January 30, 2020

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-