Company ยท US
Millar Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2011. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 |
| JOP | Transducer, Ultrasonic | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 |
| KRB | Probe, Thermodilution | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2011 | K112323 | CARDIA-CATH Millar Instruments, Inc. | DXO |
| Jan 5, 2010 | K093111 | MIKRO-CATH, MODEL 825-0101 Millar Instruments, Inc. | DXO |
| Jul 2, 2002 | K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 Millar Instruments, Inc. | DRQ |
| Mar 1, 2000 | K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER Millar Instruments, Inc. | DQO |
| Nov 7, 1995 | K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER Millar Instruments, Inc. | DQO |
| Aug 5, 1994 | K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER Millar Instruments, Inc. | DXO |
| Apr 20, 1992 | K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN Millar Instruments, Inc. | DXO |
| Jan 24, 1990 | K896264 | MILLAR MIKRO-TIP DOPPLER CATHETER Millar Instruments, Inc. | JOP |
| Dec 7, 1989 | K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER Millar Instruments, Inc. | DXO |
| Nov 18, 1988 | K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. | DQO |
| Jul 29, 1986 | K860766 | MILLAR PULSED DOPPLER VELOCIMETER Millar Instruments, Inc. | DPW |
| Oct 29, 1985 | K853138 | MILLAR MIKRO-TIP DOPPLER CATHETER Millar Instruments, Inc. | JOP |
| Oct 26, 1984 | K842150 | TRANSDUCER-MONITOR INTERFACING Millar Instruments, Inc. | DXO |
| Apr 18, 1983 | K830909 | MIKRO-TIP CATH. PRESSURE TRANSDUCER Millar Instruments, Inc. | KRB |
| Nov 30, 1982 | K823434 | MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. | DRF |
| Nov 16, 1981 | K812944 | MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. Millar Instruments, Inc. | DRF |
| Dec 10, 1980 | K802830 | MILLAR MIKRO-TIP CATHETER PHONOTRANS Millar Instruments, Inc. | DXW |
| Nov 15, 1979 | K792177 | MILLAR MIKRO-TIP CATHETER TRANSDUCER Millar Instruments, Inc. | DXO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2011 | Millar Instruments, Inc Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F.
Provide intravascular pressure readings and capabilit Terminated |
DQO | K952773 K993694 |
| Nov 17, 2010 | Millar Instruments, Inc Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023 Terminated |
DQO | K952773 K993694 |
| Mar 18, 2005 | Millar Instruments, Inc Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas Terminated |
DQO | K993694 |