RithmID-SD Steerable Diagnostic Electrophysiology Catheter— 510(k) K203793

Substantially Equivalent

Synaptic Medical Corporation

FDA 510(k) clearance K203793 for RithmID-SD Steerable Diagnostic Electrophysiology Catheter, Substantially Equivalent on 2022-02-14. Applicant: Synaptic Medical Corporation.

Clearance details

Applicant: Synaptic Medical Corporation
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2020-12-28
Decision date: 2022-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.