VACU-FIL TRANSFER SET— 510(k) K812928

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K812928 for VACU-FIL TRANSFER SET, Substantially Equivalent on 1981-12-30. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1981-10-19
Decision date: 1981-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.