510(k) K961039— BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL

Substantially Equivalent

Dayspring Medical, Inc.

Clearance details

Applicant: Dayspring Medical, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1996-03-14
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Adverse events under product code FJI

product code FJI

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.