PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER— 510(k) K080813

Name: FDA 510(k) clearance K080813
Creator: U.S. Food and Drug Administration
Published: 2008-07-01

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K080813 for PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER, Substantially Equivalent on 2008-07-01. Applicant: Radi Medical Systems AB. Device class: 2.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DXO
Device class: Class 2
Regulation: 21 CFR 870.2870
Advisory panel: Cardiovascular
Date received: 2008-03-21
Decision date: 2008-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.