Duns Number:601994184
Device Description: Smart Port CT Single Titanium Port System with Attached 7.5F x 66cm Silicone Catheter and Smart Port CT Single Titanium Port System with Attached 7.5F x 66cm Silicone Catheter and 8F Introducer Kit (with Valved Introducer)
Catalog Number
-
Brand Name
Smart Port CT
Version/Model Number
CT75STSA-VI
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 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"
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
K062414
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
5a0e00dc-6f5d-457e-ab0d-50c9e5821810
Public Version Date
November 04, 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 |