ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE— 510(k) K812685

Substantially Equivalent

Ericka

FDA 510(k) clearance K812685 for ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE, Substantially Equivalent on 1981-09-29. Applicant: Ericka.

Clearance details

Applicant: Ericka
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1981-09-22
Decision date: 1981-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.