SUREFLOW SAFETY INFUSION DEVICE— 510(k) K051943

Substantially Equivalent

Intrasafe Medical, LLC

FDA 510(k) clearance K051943 for SUREFLOW SAFETY INFUSION DEVICE, Substantially Equivalent on 2005-10-04. Applicant: Intrasafe Medical, LLC.

Clearance details

Applicant: Intrasafe Medical, LLC
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2005-07-18
Decision date: 2005-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.