I.V. ADMINISTRATION SET— 510(k) K810757

Substantially Equivalent

American Mcgaw

FDA 510(k) clearance K810757 for I.V. ADMINISTRATION SET, Substantially Equivalent on 1981-04-08. Applicant: American Mcgaw.

Clearance details

Applicant
American Mcgaw
Product code
Code FDA
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FDA

product code FDA
Death
8
Injury
148
Total
156

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.