Catalog Number

-

Brand Name

NA

Version/Model Number

FG02550

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

K212027

Product Code

MCW

Product Code Name

Catheter, peripheral, atherectomy

Public Device Record Key

e963461b-908e-42fc-8b82-a0c950fc85b0

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-