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

Substantially Equivalent

Dayspring Medical, Inc.

FDA 510(k) clearance K961039 for BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL, Substantially Equivalent on 1996-09-12. Applicant: Dayspring Medical, Inc.. Device class: 2.

Clearance details

Applicant
Dayspring Medical, Inc.
Product code
Code FJI
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FJI

view all

More clearances from Dayspring Medical, Inc.

view all

Adverse events under product code FJI

product code FJI
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.