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

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.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DXO
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 ↗

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.