FDA.reportPublic FDA data

TC-510 Pressure Control Unit

Primary DI
00868924000229
Brand
TC-510 Pressure Control Unit
Company
MILLAR INC.
Model
TC-510
Catalog number
851-5918
Device description
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
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842150000TRANSDUCER-MONITOR INTERFACINGMillar Instruments, Inc.1984-10-26DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868924000229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868924000229008689240002298689240002290868924000229

GMDN Terms#

Term, Definition table
TermDefinition
Transducer signal amplifierAn electronic device that increases current, voltage, or power to intensify the electrical signal sent to or received from a transducer (e.g., electroacoustic, electro-optical, electromechanical), sometimes providing impedance matching. It will provide an electrical interface between a physiological transducer and a patient monitor or patient monitoring system that is used to monitor pressures such as, noninvasive and invasive blood pressure, oesophageal pressures, urinary tract pressures, intrauterine pressures and intraocular pressures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-667-7000sales@millar.com

Regulatory Flags#

DUNS number
058269648
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer System850-5148850-51482021-07-16
00868924000205Mikro-Cath Pressure Catheter825-0101825-01012016-10-03
00868924000212Pressure Control Unit PCU-2000PCU-2000880-01292016-09-30
00868924000236Mikro-Tip Catheter Pulse TransducerSPT-301808-10192016-10-21

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