# K041134: Combomap Pressure and Flow System

- Pathway: 510(k) (Special)
- Applicant: Volcano Therapeutics, Inc.
- Decided: Jun 2, 2004 after 33 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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.
85 later devices descend from it; 8 cite it directly.
7 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021219: Smartwire/Smartmap Pressure System, Jomed, Inc. (2002) Summary page 1.
- K965140: Cardiometrics Wavewire/Wavemap Pressure System, Cardio Metrics, Inc. (1997) Summary page 1.
- K921563: Cardiometrics Flowire/Flomap System, Cardio Metrics, Inc. (1992) Summary page 1.

## Most influential descendants
- K081625: Flowpicc Stylet (2008), 40 descendants of its own
- K081626: Flowpicc Console (2008), 39 descendants of its own
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet (2009), 38 descendants of its own
- K093775: Evguide Tip Location System (2010), 34 descendants of its own
- K071554: Volcano S5/S5I Intravascular Imaging and Pressure System (2008), 28 descendants of its own

## Indications for use
ComboMapTM Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

Source page: https://510kreport.com/device/K041134
Methodology: https://510kreport.com/methodology