Catalog Number

OCB4008BA

Brand Name

FLASH MINI Ostial System

Version/Model Number

OCB4008BA

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)

-

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

K131450,K152485

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Public Device Record Key

27954038-f9b5-4ce2-b4e0-24aba14a53aa

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-