Flo Trac sensor, Volume View sensor— 510(k) K152980

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K152980 for Flo Trac sensor, Volume View sensor, Substantially Equivalent on 2016-01-19. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2015-10-09
Decision date: 2016-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.