AUTO-FILL SYRINGE KIT, MODEL 7600— 510(k) K063851

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K063851 for AUTO-FILL SYRINGE KIT, MODEL 7600, Substantially Equivalent on 2007-01-26. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2006-12-28
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.