Duns Number:081277700
Device Description: The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid ( The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.
Catalog Number
37.550.501
Brand Name
CerebloFlo®
Version/Model Number
37.550.501
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
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
K170599,K170599,K170599
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
120ed57c-93f2-4068-b7e8-904b6c39370f
Public Version Date
March 30, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2022
Package DI Number
30381780530132
Quantity per Package
5
Contains DI Package
10381780530138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |