Duns Number:531408342
Device Description: The Intraventricular Monitoring Catheter Set (IVMCS) contains: a 35 cm Radiopaque Ventricu The Intraventricular Monitoring Catheter Set (IVMCS) contains: a 35 cm Radiopaque Ventricular Catheter with large holes and graphite length marks at 5, 10, 15 cm from the tip; a Catheter passer with barbed end; a F8 Luer lock connector; a 35 cm introducer; a 20 cm introducer; a Slit suture clamp; a Watertight cap; a T-Connector/Stopcock Assembly (male Luer lock T-Connector with self-sealing injection/sampling port, drainage tube, four-way stopcock with two female Luer Lock outlet connectors, and watertight cap).
Catalog Number
910130A
Brand Name
Intraventricular Monitoring Catheter Set
Version/Model Number
910130A
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"
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
K855058,K914995
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
85f80cc7-7720-4d4e-8522-17c6306e03ef
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |