Catalog Number

OTW6012BA

Brand Name

FLASH Ostial System OTW

Version/Model Number

OTW6012BA

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

K150946

Product Code

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Public Device Record Key

ba24e600-f649-43d9-92d7-8a17bee7feaf

Public Version Date

August 09, 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

-