Duns Number:006261481
Device Description: CATHETER 6218A003 ATTAIN GLOBAL
Catalog Number
-
Brand Name
ATTAIN® ACCESS
Version/Model Number
6218A003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 04, 2019
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
K112917
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
f22e9b97-846d-410d-9a27-232e801a3d5b
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
April 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |