Duns Number:058269648
Device Description: The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of anystandardized sensitivity Mikro-Tip® catheter and strain gauge pressure monitors or recordingsystems which supply bridge excitation voltage and have balance and calibration controls forfull-bridge strain gauge pressure transducers.The TC-510 contains circuitry which facilitates monitor setup. In the STANDBY (0) positionthe TC-510 provides an electrical zero. In the 100 mmHg (13.3 kPa) position the TC-510provides a signal equal to 100 mmHg (13.3 kPa) at a sensitivity of 5 μV/V/mmHg. Thetransducer is operational in the TRANSDUCER position and the TRANSDUCER BALANCEcontrol allows balancing of the transducer
Catalog Number
851-5918
Brand Name
TC-510 Pressure Control Unit
Version/Model Number
TC-510
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K842150
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
70df8f19-161c-43b2-878b-276b7129a0de
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 30, 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 |