Duns Number:134139174
Device Description: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Catalog Number
ICF100
Brand Name
THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Version/Model Number
ICF100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K132175,K163693
Product Code
DXC
Product Code Name
CLAMP, VASCULAR
Public Device Record Key
a5784b97-d793-4a6a-8846-462527214d9f
Public Version Date
August 25, 2021
Public Version Number
5
DI Record Publish Date
August 31, 2016
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. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |