# K070011: Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Biomedical,Inc.(Ibi)
- Decided: Mar 20, 2007 after 76 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
Longest line of descent: 4 generations back to K921148 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042593: Acuson Acunav 8F Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K033650: Acunav 90/10 Diagnostic Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K992631: Acunav Diagnostic Ultrasound Catheter, Acuson Corp. (1999). Our reading of the summary gave K992632, FDA’s number for Immulite Amphetamine, Models LKAM1, LKAM5 (Diagnostic Products Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ACUSON AcuNav Diagnostic Ultrasound Catheter”.

## Indications for use
The IBI InquiryTM ClearICETM Intracardiac Echocardiography Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac anatomy and physiology as well as visualization of other devices in the heart.

Source page: https://510kreport.com/device/K070011
Methodology: https://510kreport.com/methodology