# K070487: Smartwire Pressure Guide Wire, Model 66XX

- Pathway: 510(k) (Special)
- Applicant: Volcano Corporation
- Decided: Mar 16, 2007 after 24 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K823434 (1982). 13 ancestors in all.
44 later devices descend from it; 2 cite it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002) Summary page 1.

## Most influential descendants
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own
- K082229: S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System (2008), 25 descendants of its own
- K111706: Volcano S5IINTRAVASCULAR Imaging and Pressure System (2011), 24 descendants of its own
- K123898: Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System (2013), 21 descendants of its own
- K133323: Volcano Ifr Modality (2014), 18 descendants of its own

## Indications for use
The SmartWire Pressure Guide Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Source page: https://510kreport.com/device/K070487
Methodology: https://510kreport.com/methodology