Duns Number:008999906
Device Description: Each LANGSTON dual lumen catheter is indicated for delivery of contrast medium in angiogra Each LANGSTON dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Catalog Number
-
Brand Name
Langston® dual lumen catheter
Version/Model Number
5545
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
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
9f57acdb-ff59-4c91-a890-f84926274d7b
Public Version Date
November 11, 2019
Public Version Number
4
DI Record Publish Date
September 05, 2016
Package DI Number
M20655451
Quantity per Package
5
Contains DI Package
M20655450
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |