Cardio Metrics, Inc.
Houston, TX, US
Cardio Metrics, Inc. appears in FDA device records in Houston, TX. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Cardio Metrics, Inc. between 1986 and 1997. The busiest year on record is 1994, with 4. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972762 | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES | DQX | Substantially Equivalent | |
| K965140 | CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM | DQX | Substantially Equivalent | |
| K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | ITX | Substantially Equivalent | |
| K961777 | ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 | DQX | Substantially Equivalent | |
| K955551 | CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 | DQX | Substantially Equivalent | |
| K954913 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) | DQX | Substantially Equivalent | |
| K952562 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE | DQX | Substantially Equivalent | |
| K943022 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE | DQX | Substantially Equivalent | |
| K940984 | CARDIOMETRICS DUALFLOW SWITCH BOX | DQX | Substantially Equivalent | |
| K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT | IYO | Substantially Equivalent | |
| K941485 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES | DQX | Substantially Equivalent | |
| K932536 | CARDIOMETRICS FLOWIRE & FLOMAP | ITX | Substantially Equivalent | |
| K925524 | CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) | DPW | Substantially Equivalent | |
| K921563 | CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM | ITX | Substantially Equivalent | |
| K912776 | CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND | ITX | Substantially Equivalent | |
| K905411 | FLOWIRE AND FLOMAP | DPW | Substantially Equivalent | |
| K900860 | PERFUSION MONITOR | DTY | Substantially Equivalent | |
| K901733 | MODIFIED FLOCATH PULMONARY ARTERY CATHETER | DPW | Substantially Equivalent | |
| K882593 | MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM | DPW | Substantially Equivalent | |
| K870150 | CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM | JOP | Substantially Equivalent | |
| K863482 | DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE | GCY | Substantially Equivalent | |
| K860775 | MEDIASTINAL AUTOTRANSFUSION SYSTEM | DTP | Substantially Equivalent | |
| K860298 | STABLELINE | KRI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- DTPDefoamer, Cardiopulmonary Bypass
- DPWFlowmeter, Blood, Cardiovascular
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain