Duns Number:058269648
Device Description: Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.
Catalog Number
808-1019
Brand Name
Mikro-Tip Catheter Pulse Transducer
Version/Model Number
SPT-301
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
-
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
K895721
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
55817e2f-4286-49a2-8ce2-c320f9ff4a43
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 21, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |