Catalog Number

PD22130K

Brand Name

Phoenix Atherectomy Deflecting System , 2.2mm X 130cm 6F

Version/Model Number

PD22130K

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

-

Product Code

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Public Device Record Key

7b6ad77b-006b-494b-a576-aef7513604e4

Public Version Date

March 31, 2022

Public Version Number

3

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-