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TC-510 Pressure Control Unit

MILLAR INC. · Model TC-510 · UDI-DI 00868924000229

DXO

510(k) clearances

2,406

Adverse events (21 deaths)

Recalls

Facilities

Description

The TC-510 Pressure Control Unit is a passive interface between the pressure sensor of any standardized sensitivity Mikro-Tip® catheter and strain gauge pressure monitors or recording systems which supply bridge excitation voltage and have balance and calibration controls for full-bridge strain gauge pressure transducers. The TC-510 contains circuitry which facilitates monitor setup. In the STANDBY (0) position the TC-510 provides an electrical zero. In the 100 mmHg (13.3 kPa) position the TC-510 provides a signal equal to 100 mmHg (13.3 kPa) at a sensitivity of 5 μV/V/mmHg. The transducer is operational in the TRANSDUCER position and the TRANSDUCER BALANCE control allows balancing of the transducer

Recalls

Date	Firm	Reason
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2015-11-13	Edwards Lifesciences, LLC	Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devic
2015-07-31	Edward Lifesciences, Llc	Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the sys

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.