FDA.reportPublic FDA data

Millar LLC.

Matched from indexed company URL: MILLAR INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30276051681625382Millar LLC.1N2026-01-0111950 N. Spectrum -- Houston TX US 77047
16253821625382MILLAR INC.1N2020-04-256001 Gulf Fwy HOUSTON TX US 77023

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00868924000205Mikro-Cath Pressure Catheter - 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.832-667-7131jjean-baptiste@millar.com
00868924000229TC-510 Pressure Control Unit - 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 transducer832-667-7000sales@millar.com
00868924000236Mikro-Tip Catheter Pulse Transducer - 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.832-667-7000sales@millar.com
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer System - The 850-5148 cable is designed as an interface between the Millar Mikro-CathTM catheter (Part #825-0101-5), and the Schwarzer Cardiotek GmbH medical device as detailed below: EP-Tracer 38, EP-Tracer 70, EP-Tracer 102, when used with the following system configurations: EP-Tracer Portable, EP-Tracer Stationary, EP-Tracer ProCart. The 850-5148 cable is 10 feet long. The cable is supplied nonsterile.8326677100sales@millar.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
31631562773223K895721MILLAR MIKRO-TIP PULSE TRANSDUCERDXO1989-12-07
3190221562773223K895721MILLAR MIKRO-TIP PULSE TRANSDUCERDXO1989-12-07
31631371714587K842150TRANSDUCER-MONITOR INTERFACINGDXO1984-10-26
3190221371714587K842150TRANSDUCER-MONITOR INTERFACINGDXO1984-10-26
31631387405595K163376Mikro-Cath Pressure CatheterDXO2017-03-10
3190221387405595K163376Mikro-Cath Pressure CatheterDXO2017-03-10
31631969147140K112323CARDIA-CATHDXO2011-10-18
31632061399655K093111MIKRO-CATH, MODEL 825-0101DXO2010-01-05
3190222061399655K093111MIKRO-CATH, MODEL 825-0101DXO2010-01-05
31631380520233K013205MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000DRQ2002-07-02
3190221380520233K013205MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000DRQ2002-07-02
3190222012885898

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXO92017-03-10
DRQ22002-07-02

PMN#

GUDID#

Pressure Control Unit PCU-2000 - The twochannelPCU-2000, M.I. P/N 880-0129, is an essential interface between one dual-pressure or twosingle-pressure Mikro-Tip catheters and a CE-approved data acquisition system or patient monitor. Theunit 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 patientsafety. These inputs are also protected against the effects of a cardiac defibrillator discharge. Thedischarge 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 monitorsand computer data acquisition systems. The amplifier provides bridge excitation voltage, separatebalance (zero) controls and lighted push buttons for electronic calibrations of 0, 25, 100 or 125 mmHgfor both channels.The PCU-2000 allows selection of standby mode to verify zero and calibration. The output connectorsare standard ¼-inch phone jacks. Output cables are not provided.

MILLAR INC.

2016-09-30

TC-510 Pressure Control Unit - 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

MILLAR INC.

2016-09-30