VAMP Optima closed blood sampling system— 510(k) K180275

Name: FDA 510(k) clearance K180275
Creator: U.S. Food and Drug Administration
Published: 2018-10-24

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K180275 for VAMP Optima closed blood sampling system, Substantially Equivalent on 2018-10-24. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2018-01-31
Decision date: 2018-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.