Catalog Number

-

Brand Name

PHOENIX ATHERECTOMY DEFLECTING SYSTEM, 2.4MM X 130CM, 7F

Version/Model Number

PD24130K

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

K211518

Product Code

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Public Device Record Key

177fd94f-5404-49a7-b618-b5815fa0680f

Public Version Date

March 31, 2022

Public Version Number

2

DI Record Publish Date

October 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-