Duns Number:531408342
Device Description: Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, Ventricular Catheters are provided Straight, Finned or Right Angle (inner diameter 1.4mm, outer diameter 2.7mm). They are delivered with an Introducer. Marked Ventricular Catheters feature radiopaque Length Markings at 2.0 cm Intervals from the Tip. A Straight or Right Angle Connector, and/or a silicone Right Angle Guide, are supplied as Accessories.
Catalog Number
9MZ206
Brand Name
Ventricular Catheter
Version/Model Number
9MZ206
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K911433
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
23a38ab6-39fe-46a1-956c-9cf58c910ebf
Public Version Date
July 06, 2018
Public Version Number
3
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 |