COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE— 510(k) K103715

Substantially Equivalent

Mirador Biomedical, Inc.

FDA 510(k) clearance K103715 for COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE, Substantially Equivalent on 2011-01-20. Applicant: Mirador Biomedical, Inc..

Clearance details

Applicant: Mirador Biomedical, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2010-12-21
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Special
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.