COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST— 510(k) K112203

Substantially Equivalent

Mirador Biomedical, Inc.

FDA 510(k) clearance K112203 for COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST, Substantially Equivalent on 2011-12-14. Applicant: Mirador Biomedical, Inc..

Clearance details

Applicant: Mirador Biomedical, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2011-08-01
Decision date: 2011-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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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.