RHYTHMIA HDx Mapping System (with software Version 2.0)— 510(k) K173837

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K173837 for RHYTHMIA HDx Mapping System (with software Version 2.0), Substantially Equivalent on 2018-07-25. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2017-12-18
Decision date: 2018-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.