Duns Number:079105071
Device Description: AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 21 R/O Markers
Catalog Number
-
Brand Name
AccuVu
Version/Model Number
53709021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 19, 2021
Issuing Agency
In HIBCC
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
K112452,K112452
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
ec377564-d7f9-4b4f-b980-97e9e3e7c413
Public Version Date
March 23, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
H787537090215
Quantity per Package
5
Contains DI Package
H787537090210
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |