# K965140: Cardiometrics Wavewire/Wavemap Pressure System

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Metrics, Inc.
- Decided: Aug 18, 1997 after 238 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K823434 (1982). 11 ancestors in all.
92 later devices descend from it; 5 cite it directly.
7 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905411: Flowire and Flomap, Cardio Metrics, Inc. (1991) Summary page 3.
- K912776: Cardiometrics Flowire/Flomap Doppler Ultrasound, Cardio Metrics, Inc. (1992) Summary page 3.
- K921563: Cardiometrics Flowire/Flomap System, Cardio Metrics, Inc. (1992) Summary page 3.
- K932536: Cardiometrics Flowire & Flomap, Cardio Metrics, Inc. (1993) Summary page 3.
- K941485: Cardiometrics Flowire Doppler Guide Wires, Cardio Metrics, Inc. (1994) Summary page 3.
- K943022: Cardiometrics Flowire Doppler Guide Wire, Cardio Metrics, Inc. (1994) Summary page 3.
- K955551: CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404, Cardio Metrics, Inc. (1996) Summary page 3.
- K952562: Cardiometrics Accutrac Intravascular Guide Wire, Cardio Metrics, Inc. (1995) Summary page 3.
- K961777: Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404, Cardio Metrics, Inc. (1996) Summary page 3.
- K862673: Model 6615 Floscan Doppler Diagnostic Catheter, Medtronic Vascular (1986) Summary page 3.
- K823434: Mikro-Tip Catheter Pressure Transducer, Millar Instruments, Inc. (1982) Summary page 3.

## Most influential descendants
- K021219: Smartwire/Smartmap Pressure System (2002), 90 descendants of its own
- K041134: Combomap Pressure and Flow System (2004), 85 descendants of its own
- K070487: Smartwire Pressure Guide Wire, Model 66XX (2007), 44 descendants of its own
- K081625: Flowpicc Stylet (2008), 40 descendants of its own
- K081626: Flowpicc Console (2008), 39 descendants of its own

## Indications for use
The Cardiometrics WaveWire/WaveMap Pressure System is intended for use in coronary and peripheral blood vessels to measure blood pressure during diagnostic and/or interventional procedures. The WaveWire may be used to guide the positioning of balloon dilatation catheters, as well as other interventional devices such as atherectomy devices, lasers and stents. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary and/or peripheral artery disease.

Source page: https://510kreport.com/device/K965140
Methodology: https://510kreport.com/methodology