Duns Number:969986236
Device Description: ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion ClariVein® IC is a specialty infusion cathether with 360 degree rotatable fluid dispersion wire connected to a proximally located integral battery motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features to facilitate physician-controlled infusion of the selected agent. The ClariVein® IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The ClariVein® IC has no user serviceable parts or capital equipment. It is fully disposable.
Catalog Number
85-018-E140S
Brand Name
ClariVein® IC
Version/Model Number
85-018-E140S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 03, 2020
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
-
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
778cfaef-3cb2-451c-b169-88c9b4154220
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 19, 2016
Package DI Number
30854339004038
Quantity per Package
5
Contains DI Package
10854339004034
Package Discontinue Date
November 03, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |