Duns Number:018860556
Device Description: The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Catalog Number
89185J
Brand Name
OmniWire Pressure Guide Wire, J-Tip
Version/Model Number
J-Tip 89185J
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"
Yes
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
K192886
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
6221f614-fa25-45da-b750-cf8222ed1706
Public Version Date
February 28, 2022
Public Version Number
3
DI Record Publish Date
April 20, 2020
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. | 42 |
| 3 | A medical device with high risk that requires premarket approval | 58 |