Duns Number:008999906
Device Description: The Venture catheter is indicated for directing, steering, controlling, and supporting a g The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
Catalog Number
-
Brand Name
Venture® OTW catheter
Version/Model Number
5821
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
6bba231c-9b19-4ad3-a315-1c1717a67559
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 05, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |