CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508— 510(k) K042381

Substantially Equivalent

Acumen Medical, Inc.

FDA 510(k) clearance K042381 for CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508, Substantially Equivalent on 2004-12-28. Applicant: Acumen Medical, Inc..

Clearance details

Applicant: Acumen Medical, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2004-09-01
Decision date: 2004-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.