ADAGIO RETRACTING ECG LEAD WIRES— 510(k) K093657

Substantially Equivalent

Acist Medical Systems, Inc.

FDA 510(k) clearance K093657 for ADAGIO RETRACTING ECG LEAD WIRES, Substantially Equivalent on 2010-01-15. Applicant: Acist Medical Systems, Inc..

Clearance details

Applicant: Acist Medical Systems, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2009-11-25
Decision date: 2010-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.