RFP-100A Connector Cable (Single Use)— 510(k) K230571

Substantially Equivalent

Baylis Medical Technologies, Inc.

FDA 510(k) clearance K230571 for RFP-100A Connector Cable (Single Use), Substantially Equivalent on 2023-05-30. Applicant: Baylis Medical Technologies, Inc..

Clearance details

Applicant: Baylis Medical Technologies, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2023-03-01
Decision date: 2023-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
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.