TC-510 Pressure Control Unit

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…

Registry build 21.09.26

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

4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DXO
Manufacturer City Province Registered as Device types
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Suzhou Prosteri Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 20
Beijing Bywave Sensing Medical Technology Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for TC-510 Pressure Control Unit
Listed by Millar LLC., United States
FDA product code DXO
Device type Transducer, Pressure, Catheter Tip
Device class Class 2
Regulation 21 CFR 870.2870
Establishment Contract manufacturer, Manufacturer
510(k) K842150
Record published 2016-09-30
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number

Catalogue Numbers

Catalogue numbers for TC-510 Pressure Control Unit
Catalogue number Size Status
TC-510 In distribution

Same Product Code

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Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K163376 2017-03-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer