ENTERAL NUTRITION PUMPS PN 1000 AND VM 05— 510(k) K860086

Substantially Equivalent

Vial Medical , Ltd.

FDA 510(k) clearance K860086 for ENTERAL NUTRITION PUMPS PN 1000 AND VM 05, Substantially Equivalent on 1986-03-24. Applicant: Vial Medical , Ltd..

Clearance details

Applicant: Vial Medical , Ltd.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1986-01-09
Decision date: 1986-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: H4r 2a4 Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.