Catalog Number

152-110P

Brand Name

Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip)

Version/Model Number

152-110P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

K920873

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

d4414ef0-918a-4040-8dba-ca6a9279e916

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

October 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-