Duns Number:002348191
Device Description: Arrow-Clark(TM) VectorFlow(TM) Retrograde Replacement Hub Set Fits 15 Fr. x 55 cm Models
Catalog Number
VF-15552-E
Brand Name
ARROW
Version/Model Number
IPN001405
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2016
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141051,K141051,K141051
Product Code
MDS
Product Code Name
Sensor, glucose, invasive
Public Device Record Key
74879689-eb83-499e-b83d-d0d7ab103699
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40801928128856
Quantity per Package
1
Contains DI Package
30801927128850
Package Discontinue Date
October 05, 2016
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |