Cardiometrics Flowire/Flomap Doppler Ultrasound
FDA 510(k) K912776 · Cardio Metrics, Inc.
510(k) numberK912776
Submission
- Device name
- Cardiometrics Flowire/Flomap Doppler Ultrasound
- Applicant
- Cardio Metrics, Inc.
Mountain View, CA, US - Received
- June 24, 1991
- Decision date
- January 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
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More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresDQX · Traditional | 10/14/1997SE |
| K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemDQX · Traditional | 08/18/1997SE |
| K951567 | Cardiometics Flowire, Smartwire Doppler Guide WireITX · Traditional | 10/25/1996SE |
| K961777 | Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404DQX · Traditional | 07/31/1996SE |
| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification)DQX · Traditional | 11/07/1995SE |
| K952562 | Cardiometrics Accutrac Intravascular Guide WireDQX · Traditional | 08/29/1995SE |
| K943022 | Cardiometrics Flowire Doppler Guide WireDQX · Traditional | 09/19/1994SE |
| K940984 | Cardiometrics Dualflow Switch BoxDQX · Traditional | 08/18/1994SE |
| K933320 | Cardiometrics Flomap and Flomod Ultrasound InstrumentIYO · Traditional | 08/17/1994SE |
Questions and answers
When was Cardiometrics Flowire/Flomap Doppler Ultrasound cleared by the FDA?
Cardiometrics Flowire/Flomap Doppler Ultrasound (K912776) received a 510(k) decision of Substantially Equivalent on January 9, 1992, 199 days after the submission was received.
What is the product code of K912776?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.