Catalog Number

LX35757100V

Brand Name

LUTONIX® Drug Coated Balloon

Version/Model Number

LX35757100V

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PRC

Product Code Name

Drug-coated peripheral transluminal angioplasty catheter

Public Device Record Key

803fdd7e-a41b-42f8-a11c-9344d9f74df0

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

January 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-