# K921879: Cbis Catheter Pull-Back Device

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Systems, Inc.
- Decided: Jul 16, 1992 after 87 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- 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
No predicates in its family tree.
33 later devices descend from it; 1 cites it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974457: Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout Imaging Catheter Patient T (1998), 32 descendants of its own
- K050995: Revolution 45 MHZ Rotational Ivus Imaging Catheter (2005), 31 descendants of its own
- 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

Source page: https://510kreport.com/device/K921879
Methodology: https://510kreport.com/methodology