# K170204: FFR Link, FFR Signal Processing Module

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 24, 2017 after 60 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003122 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151613: iLab Polaris Multi-Modality Guidance System, Boston Scientific Corporation (2015) Summary page 4.

## Recalls of this device
- May 15, 2017 · Class II · Z-3132-2017: The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.

## Indications for use
The FFR Link ™ is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab™ POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable.

Source page: https://510kreport.com/device/K170204
Methodology: https://510kreport.com/methodology