RITHM ID ELECTROPHYSIOLOGY CATHETER— 510(k) K133028

Substantially Equivalent

Synaptic Medical Limited

FDA 510(k) clearance K133028 for RITHM ID ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 2014-03-04. Applicant: Synaptic Medical Limited.

Clearance details

Applicant: Synaptic Medical Limited
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2013-09-26
Decision date: 2014-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.