Duns Number:058269648
Device Description: The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure s The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound.
Catalog Number
825-0101
Brand Name
Mikro-Cath Pressure Catheter
Version/Model Number
825-0101
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
K093111
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
2a5b4aff-2b15-48ba-96d1-97e4d9830d8e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 03, 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 |