STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE— 510(k) K800864

Substantially Equivalent

Custom Medical Devices Intl., Inc.

FDA 510(k) clearance K800864 for STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE, Substantially Equivalent on 1980-05-30. Applicant: Custom Medical Devices Intl., Inc..

Clearance details

Applicant: Custom Medical Devices Intl., Inc.
Product code: Code FMG
Advisory panel: General Hospital
Date received: 1980-04-16
Decision date: 1980-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.