Duns Number:784259751
Device Description: Z6135 ATRIO BALLOON CATHETER 13.5MM
Catalog Number
611051
Brand Name
Z-6™
Version/Model Number
611051
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)
-
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
K211910
Product Code
DXF
Product Code Name
CATHETER, SEPTOSTOMY
Public Device Record Key
9bf4ec84-0dab-406e-b034-0d0152856e36
Public Version Date
September 13, 2021
Public Version Number
1
DI Record Publish Date
September 04, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1226 |
3 | A medical device with high risk that requires premarket approval | 361 |