Duns Number:715919973
Device Description: The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and gu The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
Catalog Number
-
Brand Name
CELLO™, Balloon Guide Catheter
Version/Model Number
1610590
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K120781,K120781,K120781
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
f4ae9477-0b83-46c2-9c0e-6acf40b7eddf
Public Version Date
January 26, 2022
Public Version Number
1
DI Record Publish Date
January 18, 2022
Package DI Number
14544050120743
Quantity per Package
1
Contains DI Package
04544050120746
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |