MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6— 510(k) K063774

Substantially Equivalent

Concentric Medical, Inc.

FDA 510(k) clearance K063774 for MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6, Substantially Equivalent on 2007-01-24. Applicant: Concentric Medical, Inc..

Clearance details

Applicant: Concentric Medical, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2006-12-21
Decision date: 2007-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

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Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.