DEFLECTING URETERAL ACCESS SHEATH— 510(k) K030642

Substantially Equivalent

Applied Medical Resources Corp.

FDA 510(k) clearance K030642 for DEFLECTING URETERAL ACCESS SHEATH, Substantially Equivalent on 2003-05-23. Applicant: Applied Medical Resources Corp..

Clearance details

Applicant: Applied Medical Resources Corp.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-28
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.