FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH— 510(k) K033569

Substantially Equivalent

Flowmedica, Inc.

FDA 510(k) clearance K033569 for FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH, Substantially Equivalent on 2004-01-13. Applicant: Flowmedica, Inc..

Clearance details

Applicant: Flowmedica, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2003-11-12
Decision date: 2004-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.