DeviceClearance

ERIKA HEPARIN INFUSION ADAPTOR— 510(k) K810824

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K810824 for ERIKA HEPARIN INFUSION ADAPTOR, Substantially Equivalent on 1981-04-17. Applicant: Erika, Inc.. Device class: 2.

Clearance details

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

Recent devices under product code FJK

view all

More clearances from Erika, Inc.

view all

Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

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.