ISOFLOW INFUSION CATHETER— 510(k) K081147

Substantially Equivalent

Vascular Designs, Inc.

FDA 510(k) clearance K081147 for ISOFLOW INFUSION CATHETER, Substantially Equivalent on 2009-05-29. Applicant: Vascular Designs, Inc..

Clearance details

Applicant: Vascular Designs, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2008-04-22
Decision date: 2009-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.