Vial2Bag Advanced 20mm Admixture Device— 510(k) K201415

Substantially Equivalent

West Pharmaceutical Services Az, Inc.

FDA 510(k) clearance K201415 for Vial2Bag Advanced 20mm Admixture Device, Substantially Equivalent on 2020-10-21. Applicant: West Pharmaceutical Services Az, Inc..

Clearance details

Applicant: West Pharmaceutical Services Az, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2020-05-29
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.