MALE-MALE LUER LOCK CONNECTOR W/ROTA— 510(k) K840797

Clearance details

Applicant

American Pharmaseal Div. Ahsc

Product code

Code DTL

Device class

Class 2

Regulation

21 CFR 870.4290

Advisory panel

Cardiovascular

Date received

1984-02-23

Decision date

1984-04-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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Malfunction

770

Total

770

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 →