Catalog Number

-

Brand Name

SolitaireTM

Version/Model Number

SFR3-6-40-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K160641

Product Code

NRY

Product Code Name

CATHETER, THROMBUS RETRIEVER

Public Device Record Key

a3b816b2-8834-41e3-88c3-3cbb573e0104

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

April 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-