VIAL-MATE Adaptor— 510(k) K142600

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K142600 for VIAL-MATE Adaptor, Substantially Equivalent on 2014-11-19. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2014-09-15
Decision date: 2014-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Lake, IL, 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.