Duns Number:089176922
Device Description: The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
Catalog Number
-
Brand Name
Aqueduct SED
Version/Model Number
ACC-CON-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2017
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
-
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
K161605,K161605
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
11a5bb11-cace-462a-a6ce-4d7796b7cf89
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 04, 2017
Package DI Number
ACCCON200
Quantity per Package
1
Contains DI Package
ACCCON100
Package Discontinue Date
September 27, 2017
Package Status
Not in Commercial Distribution
Package Type
Service Console
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |