Duns Number:601994184
Device Description: Vortex LP Low Profile Titanium Port System with Detached 8.4F and 9.6F x 76cm Silicone Cat Vortex LP Low Profile Titanium Port System with Detached 8.4F and 9.6F x 76cm Silicone Catheters
Catalog Number
-
Brand Name
Vortex
Version/Model Number
P12355K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 23, 2021
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K010189
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
84e5b06c-e283-4983-8f21-9152cfaf9523
Public Version Date
November 30, 2021
Public Version Number
4
DI Record Publish Date
September 17, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |