Duns Number:531408342
Device Description: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropyle The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.
Catalog Number
999301
Brand Name
CSF Reservoir
Version/Model Number
999301
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
K950315
Product Code
LKG
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
Public Device Record Key
c82cbe43-11b5-46e1-ab35-bbdadfc3f21d
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 |