Company ยท US
Cardio Metrics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1997. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 9 |
| DPW | Flowmeter, Blood, Cardiovascular | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| JOP | Transducer, Ultrasonic | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 1997 | K972762 | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES Cardio Metrics, Inc. | DQX |
| Aug 18, 1997 | K965140 | CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM Cardio Metrics, Inc. | DQX |
| Oct 25, 1996 | K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE Cardio Metrics, Inc. | ITX |
| Jul 31, 1996 | K961777 | ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 Cardio Metrics, Inc. | DQX |
| Feb 28, 1996 | K955551 | CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 Cardio Metrics, Inc. | DQX |
| Nov 7, 1995 | K954913 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) Cardio Metrics, Inc. | DQX |
| Aug 29, 1995 | K952562 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE Cardio Metrics, Inc. | DQX |
| Sep 19, 1994 | K943022 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE Cardio Metrics, Inc. | DQX |
| Aug 18, 1994 | K940984 | CARDIOMETRICS DUALFLOW SWITCH BOX Cardio Metrics, Inc. | DQX |
| Aug 17, 1994 | K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT Cardio Metrics, Inc. | IYO |
| May 31, 1994 | K941485 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES Cardio Metrics, Inc. | DQX |
| Sep 28, 1993 | K932536 | CARDIOMETRICS FLOWIRE & FLOMAP Cardio Metrics, Inc. | ITX |
| Aug 23, 1993 | K925524 | CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) Cardio Metrics, Inc. | DPW |
| Jul 1, 1992 | K921563 | CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM Cardio Metrics, Inc. | ITX |
| Jan 9, 1992 | K912776 | CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND Cardio Metrics, Inc. | ITX |
| Mar 29, 1991 | K905411 | FLOWIRE AND FLOMAP Cardio Metrics, Inc. | DPW |
| Aug 14, 1990 | K900860 | PERFUSION MONITOR Cardio Metrics, Inc. | DTY |
| Jul 16, 1990 | K901733 | MODIFIED FLOCATH PULMONARY ARTERY CATHETER Cardio Metrics, Inc. | DPW |
| Aug 29, 1988 | K882593 | MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM Cardio Metrics, Inc. | DPW |
| Aug 7, 1987 | K870150 | CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM Cardio Metrics, Inc. | JOP |
| Oct 14, 1986 | K863482 | DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE Cardio Metrics, Inc. | GCY |
| May 28, 1986 | K860775 | MEDIASTINAL AUTOTRANSFUSION SYSTEM Cardio Metrics, Inc. | DTP |
| Apr 2, 1986 | K860298 | STABLELINE Cardio Metrics, Inc. | KRI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||