# K201713: AVVIGO Guidance System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 23, 2020 after 30 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003122 (2001). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201178: iLab Polaris Multi-Modality Guidance System, Boston Scientific (2020) Summary page 4.

## Most influential descendants
- K212490: AVVIGO Guidance System II (2021), 3 descendants of its own
- K230884: AVVIGO'+ Multi-Modality Guidance System (2023), 1 descendant of its own
- K253692: AVVIGO™+ Multi-Modality Guidance System (2026), 0 descendants of its own
- K221340: iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (2023), 0 descendants of its own

## Indications for use
FFR and DFRTM are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

Source page: https://510kreport.com/device/K201713
Methodology: https://510kreport.com/methodology