Catalog Number

2200-2015-B

Brand Name

AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating

Version/Model Number

2200-2015-B

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

P050018

Product Code

NWX

Product Code Name

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Public Device Record Key

a09b4c3a-b088-4562-b334-9465bdbc5556

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-