GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582— 510(k) K073200

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K073200 for GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582, Substantially Equivalent on 2008-02-01. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2007-11-13
Decision date: 2008-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.