# K243884: Tavipilot

- Pathway: 510(k) (Traditional)
- Applicant: Caranx Medical
- Decided: Jul 7, 2025 after 201 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 95 ancestors in all.
No later device cites it as a predicate yet.
1 of 96 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140138: Heartnavigator Release 2.0, Philips Medical Systems Nederland B.V. (2014) Summary page 5.

## Indications for use
TAVIPILOT is an intra-operative software which provides real-time fluoroscopy detection, tracking and marking of the Non-Coronary Cusp and the prosthetic valve, to allow optimal guidance for precise positioning of the prosthetic valve, according to the planning phase, for TAVI/TAVR (transcatheter aortic valve implantation/replacement) procedures. The guidance provided by TAVIPILOT is not intended to substitute the cardiac surgeon’s or the interventional cardiologist’s judgment and analysis of the patient’s condition. The device is only intended for adults (i.e., 21 years and older). Contra-indications: - Patients who have already undergone a TAVI/TAVR or SAVR (surgical aortic valve replacement) - Patients diagnosed with aortic insufficiency - Patients for whom the main access for the TAVI/TAVR catheter is not femoral - Patients who have a non-tricuspid native valve - Patients who have a permanent Pacemaker implant or temporary Pacemaker within 2 cm from the aortic root, other than the pacing guidewire - Patients who have thoracic surgical implants - Patients who are not adults

Source page: https://510kreport.com/device/K243884
Methodology: https://510kreport.com/methodology