Catalog Number

-

Brand Name

Riptide™

Version/Model Number

MAP-1000

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

-

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

K172448

Product Code

NRY

Product Code Name

CATHETER, THROMBUS RETRIEVER

Public Device Record Key

f2cc4a91-6fcd-4012-9dd1-b78625dffae9

Public Version Date

April 15, 2019

Public Version Number

3

DI Record Publish Date

July 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-