WAVE Clinical Platform (2.0.000)— 510(k) K250135

Substantially Equivalent

Baxter Healthcare Corp/ Excel Medical

FDA 510(k) clearance K250135 for WAVE Clinical Platform (2.0.000), Substantially Equivalent on 2026-01-16. Applicant: Baxter Healthcare Corp/ Excel Medical.

Clearance details

Applicant: Baxter Healthcare Corp/ Excel Medical
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2025-01-17
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.