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FFR Link, FFR Signal Processing Module

by Boston Scientific

510(k) K170204

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170204 Date24 Mar 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3132-2017 FDA Class II initiated 15 May 2017

    The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DRG
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 870.2910
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FFR Link is a signal processing module used in cath labs during fractional flow reserve (FFR) procedures. It receives aortic pressure (Pa) signals from an invasive blood pressure transducer and distal pressure (Pd) signals from a Boston Scientific pressure guidewire.

The device can distribute physiological signals by cable and is used with COMET™ II, AVVIGO™+ Guidance System, AVVIGO™ Guidance System II, AVVIGO™ Guidance System (for physiology only), Polaris™ Multi-Modality Guidance System, or directly with compatible hemodynamic systems. It is a Class II device with FDA 510(k) clearance (K170204) and is manufactured by Boston Scientific.

Other devices from Boston Scientific

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FFR Link used for in cath labs?

    The FFR Link is a signal processing module used during fractional flow reserve (FFR) procedures to process aortic pressure signals from an invasive blood pressure transducer and distal pressure signals from a Boston Scientific pressure guidewire.

  • Which systems is the FFR Link compatible with?

    The FFR Link can be used with COMET™ II, AVVIGO™+ Guidance System, AVVIGO™ Guidance System II, AVVIGO™ Guidance System (for physiology only), Polaris™ Multi-Modality Guidance System, or directly with compatible hemodynamic systems.

  • Is the FFR Link a single-use or reusable device?

    The device data does not specify whether the FFR Link is single-use or reusable, so this information is not available from the provided documentation.

  • What is the regulatory status of the FFR Link?

    The FFR Link is a Class II device with FDA 510(k) clearance (K170204) and is manufactured by Boston Scientific, as stated in the device data.

  • How are physiological signals distributed by the FFR Link?

    The FFR Link distributes physiological signals by cable, as mentioned in the device description, allowing for integration with various guidance systems and hemodynamic monitoring equipment.