Catalog Number

EXM-4001-0000

Brand Name

Auryon Atherectomy Catheter 1.5 mm OTW

Version/Model Number

EXM-4001-0000

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

K181642,K202835

Product Code

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Public Device Record Key

88480a67-1180-4be3-b13f-cbf5110349c6

Public Version Date

December 11, 2020

Public Version Number

3

DI Record Publish Date

May 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-