# K921148: Cvis Insight Catheters for Intracardiac Use

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Systems, Inc.
- Decided: Jun 16, 1992 after 97 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,094 later devices descend from it; 1 cites it directly.
3 of 1,095 devices in its family (counting itself) have 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
- K992631: Acunav Diagnostic Ultrasound Catheter (1999), 1,093 descendants of its own
- K022567: Sequoia Signature II Diagnostic Ultrasound System (2002), 1,069 descendants of its own
- K032114: Sequoia 8.0 Diagnostic Ultrasound System (2003), 1,003 descendants of its own
- K041319: Sequoia Diagnostic Ultrasound System (2004), 988 descendants of its own
- K051139: Acuson Sequoia Diagnostic Ultrasound System (2005), 979 descendants of its own

Source page: https://510kreport.com/device/K921148
Methodology: https://510kreport.com/methodology