Data / Medical devices / United States / Millar LLC.
Millar LLC.: FDA-registered device maker in Houston, TX, United States, 4 510(k) clearances
Millar LLC. is registered with the FDA (registration 3027605168) in Houston, TX, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 10, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605168
- FEI number
- 1625382
- Address
- 11950 N. Spectrum --, Houston, TX, United States, 77047
- Owner or operator
- Millar LLC (1625382)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 22, 2008
- Registered through
- 2026
- Brand names listed
- Micro-Tip Catheter Pulse Transducer, Mikro-Cath Pressure Catheter, Transduce Signal Amplifier PCU-2000, Transducer Monitor Interface-TC-510
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Contract manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 10, 2017 | K163376 | Mikro-Cath Pressure Catheter | DXO | Substantially Equivalent | Millar, Inc. | accessdata.fda.gov |
| July 2, 2002 | K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | DRQ | Substantially Equivalent | Millar Instruments, Inc. | accessdata.fda.gov |
| December 7, 1989 | K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | DXO | Substantially Equivalent | Millar Instruments, Inc. | accessdata.fda.gov |
| October 26, 1984 | K842150 | TRANSDUCER-MONITOR INTERFACING | DXO | Substantially Equivalent | Millar Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 8, 2011 | 58123 | Not yet classified | Terminated | Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance o | Possibility of epoxy debris particles inside the catheter lumen. | accessdata.fda.gov |
| October 14, 2010 | 57015 | Not yet classified | Terminated | Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023 | The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing. | accessdata.fda.gov |
| January 14, 2005 | 30967 | Not yet classified | Terminated | Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas | Wire braiding protruding from the catheter. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Amplifier And Signal Conditioner, Transducer Signal
- All makers of Device, Monitoring, Intracranial Pressure
Updated March 10, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.