510(k) K183649— Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

Substantially Equivalent

Baylis Medical Company, Inc.

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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.