ADD-A-VIAL SOLUTION TRANSFER DEVICE— 510(k) K843639

Substantially Equivalent

American Mcgaw

FDA 510(k) clearance K843639 for ADD-A-VIAL SOLUTION TRANSFER DEVICE, Substantially Equivalent on 1985-01-14. Applicant: American Mcgaw.

Clearance details

Applicant: American Mcgaw
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1984-09-17
Decision date: 1985-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.