Duns Number:002348191
Device Description: Bipolar Balloon Electrode Catheter with shrouded pins: 5 Fr. 105 cm
Catalog Number
AI-07154-S
Brand Name
ARROW
Version/Model Number
IPN000093
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
K945229,K945229
Product Code
DRF
Product Code Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Public Device Record Key
35ad2890-a34d-4c33-9cf6-e26774a97fa1
Public Version Date
January 18, 2021
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
60801902004514
Quantity per Package
5
Contains DI Package
00801902004512
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 |