# K961777: Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Metrics, Inc.
- Decided: Jul 31, 1996 after 85 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
No predicates in its family tree.
93 later devices descend from it; 1 cites it directly.
7 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K965140: Cardiometrics Wavewire/Wavemap Pressure System (1997), 92 descendants of its own
- 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

Source page: https://510kreport.com/device/K961777
Methodology: https://510kreport.com/methodology