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Pressure Control Unit PCU-2000

MILLAR INC. · Model PCU-2000 · UDI-DI 00868924000212

510(k) clearances

Adverse events

Recalls

Facilities

Description

The twochannel PCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or two single-pressure Mikro-Tip catheters and a CE-approved data acquisition system or patient monitor. The unit is powered by a Millar-supplied external AC/DC power supply. The PCU-2000 pressure inputs (input channel 1 and input channel 2) are electrically isolated for patient safety. These inputs are also protected against the effects of a cardiac defibrillator discharge. The discharge of a cardiac defibrillator has no effect on the operation of the PCU-2000. The pressure outputs have a sensitivity of 1V/100mmHg, which is ideally compatible with most monitors and computer data acquisition systems. The amplifier provides bridge excitation voltage, separate balance (zero) controls and lighted push buttons for electronic calibrations of 0, 25, 100 or 125 mmHg for both channels. The PCU-2000 allows selection of standby mode to verify zero and calibration. The output connectors are standard ¼-inch phone jacks. Output cables are not provided.

Recalls

Date	Firm	Reason
2015-06-02	Boston Scientific Corporation	Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels b

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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.