Duns Number:799455241
Device Description: An endovascular catheter having a heat exchange element at the distal end, through which a An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 14 Fr diameter.
Catalog Number
8700-000823-01
Brand Name
InnerCool RTx 14F Standard Catheter
Version/Model Number
NA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K080908
Product Code
NCX
Product Code Name
System, Hypothermia, Intravenous, Cooling
Public Device Record Key
411c0c57-8cee-4ab7-8a5a-470111bc1052
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 331 |
| 3 | A medical device with high risk that requires premarket approval | 1 |