Cardiometrics Flowire/Flomap System
FDA 510(k) K921563 · Cardio Metrics, Inc.
510(k) numberK921563
Submission
- Device name
- Cardiometrics Flowire/Flomap System
- Applicant
- Cardio Metrics, Inc.
Mountain View, CA, US - Received
- April 1, 1992
- Decision date
- July 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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 System cleared by the FDA?
Cardiometrics Flowire/Flomap System (K921563) received a 510(k) decision of Substantially Equivalent on July 1, 1992, 91 days after the submission was received.
What is the product code of K921563?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.