Duns Number:114186877
Device Description: A simgle lumen catheter used for injection of radiopaque media and pressure measurements o A simgle lumen catheter used for injection of radiopaque media and pressure measurements of cardiovascular vessels / chambers.
Catalog Number
SF460
Brand Name
SF-NIH
Version/Model Number
317
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
K952984
Product Code
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
19225346-3cb3-41a4-bf29-d4ef39f9655b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |