Baylis Connector Cable— 510(k) K254114

Substantially Equivalent

Baylis Medical Technologies, Inc.

FDA 510(k) clearance K254114 for Baylis Connector Cable, Substantially Equivalent on 2026-01-18. Applicant: Baylis Medical Technologies, Inc..

Clearance details

Applicant: Baylis Medical Technologies, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2025-12-19
Decision date: 2026-01-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.