MODIFIED SHILEY FEMORAL VENOUS CANNULA— 510(k) K894784

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K894784 for MODIFIED SHILEY FEMORAL VENOUS CANNULA, Substantially Equivalent on 1990-03-28. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 1989-07-24
Decision date: 1990-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.