Catalog Number

ICTC088110

Brand Name

ZOOM™ 88 Large Distal Platform

Version/Model Number

ICTC088110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2022

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"

Yes

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

K212224

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

1bde61ae-1f48-4d59-9cd9-c1c925b98e1a

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-