Duns Number:945543689
Device Description: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness gui The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.
Catalog Number
N/A
Brand Name
Ballast 088 Long Sheath
Version/Model Number
BALLAST80
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
K182918
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
0c94f9b4-d40c-4bfa-b3f2-bb7dda167d5e
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
July 15, 2019
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. | 757 |