PRESSURE WIRE SENSOR, MODELS 12004/12304— 510(k) K031662

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K031662 for PRESSURE WIRE SENSOR, MODELS 12004/12304, Substantially Equivalent on 2003-06-06. Applicant: Radi Medical Systems AB.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2003-05-28
Decision date: 2003-06-06
Decision: Substantially Equivalent
Clearance type: Special
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.