Duns Number:002348191
Device Description: 7 Fr. 110 cm Berman Angiographic Balloon Catheter
Catalog Number
AI-07137
Brand Name
ARROW
Version/Model Number
IPN915833
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)
Yes
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
K892530,K892530
Product Code
DYG
Product Code Name
CATHETER, FLOW DIRECTED
Public Device Record Key
1a40dcc4-f1e1-4627-9057-605d07fe7545
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
January 27, 2020
Package DI Number
20801902161356
Quantity per Package
5
Contains DI Package
10801902161359
Package Discontinue Date
-
Package Status
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 |