AMSURE PVC INTERMITTENT CATHETER— 510(k) K091306

Substantially Equivalent

Amsino International, Inc.

FDA 510(k) clearance K091306 for AMSURE PVC INTERMITTENT CATHETER, Substantially Equivalent on 2009-08-21. Applicant: Amsino International, Inc..

Clearance details

Applicant: Amsino International, Inc.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-04
Decision date: 2009-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Pomona, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.