Millar LLC.
Houston, TX, US
Millar LLC. appears in FDA device records in Houston, TX. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Millar LLC. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Millar Instruments, Inc.510(k), recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Millar LLC. between 1979 and 2017. The busiest year on record is 1979, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163376 | Mikro-Cath Pressure Catheter | DXO | Substantially Equivalent | |
| K112323 | CARDIA-CATH | DXO | Substantially Equivalent | |
| K093111 | MIKRO-CATH, MODEL 825-0101 | DXO | Substantially Equivalent | |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | DRQ | Substantially Equivalent | |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | DXO | Substantially Equivalent | |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | DXO | Substantially Equivalent | |
| K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER | JOP | Substantially Equivalent | |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | DXO | Substantially Equivalent | |
| K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER | DQO | Substantially Equivalent | |
| K860766 | MILLAR PULSED DOPPLER VELOCIMETER | DPW | Substantially Equivalent | |
| K853138 | MILLAR MIKRO-TIP DOPPLER CATHETER | JOP | Substantially Equivalent | |
| K842150 | TRANSDUCER-MONITOR INTERFACING | DXO | Substantially Equivalent | |
| K830909 | MIKRO-TIP CATH. PRESSURE TRANSDUCER | KRB | Substantially Equivalent | |
| K823434 | MIKRO-TIP CATHETER PRESSURE TRANSDUCER | DRF | Substantially Equivalent | |
| K812944 | MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. | DRF | Substantially Equivalent | |
| K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS | DXW | Substantially Equivalent | |
| K792177 | MILLAR MIKRO-TIP CATHETER TRANSDUCER | DXO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027605168 | 1625382 | Millar LLC. | 11950 N. Spectrum, Houston, TX 77047 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRQAmplifier And Signal Conditioner, Transducer Signal
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQOCatheter, Intravascular, Diagnostic
- GWMDevice, Monitoring, Intracranial Pressure
- DPWFlowmeter, Blood, Cardiovascular
- KRBProbe, Thermodilution
- DXWSystem, Phonocatheter, Intracavitary
- DXOTransducer, Pressure, Catheter Tip
- JOPTransducer, Ultrasonic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1725-2011 | 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 of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system. | Possibility of epoxy debris particles inside the catheter lumen. | Terminated | ||
| Z-0401-2011 | 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. | Terminated | ||
| Z-0635-05 | Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas | Wire braiding protruding from the catheter. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Millar LLC. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain