LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER - LUCAS MEDICAL INC

Duns Number:878198993

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER

Version/Model Number

8FCBS100-10-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K983802

Product Code Details

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Device Record Status

Public Device Record Key

25b4341d-dc28-4872-835a-e89d00869099

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUCAS MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 169