MODIFICATION TO MERCI RETRIEVER— 510(k) K082034

Substantially Equivalent

Concentric Medical, Inc.

FDA 510(k) clearance K082034 for MODIFICATION TO MERCI RETRIEVER, Substantially Equivalent on 2008-08-15. Applicant: Concentric Medical, Inc..

Clearance details

Applicant: Concentric Medical, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2008-07-17
Decision date: 2008-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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.