TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS— 510(k) K800863

Name: FDA 510(k) clearance K800863
Creator: U.S. Food and Drug Administration
Published: 1980-05-30

Substantially Equivalent

Custom Medical Devices Intl., Inc.

FDA 510(k) clearance K800863 for TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS, Substantially Equivalent on 1980-05-30. Applicant: Custom Medical Devices Intl., Inc.. Device class: 2.

Clearance details

Applicant: Custom Medical Devices Intl., Inc.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1980-04-16
Decision date: 1980-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
K210516 — Clicky Cross2022-05-16

More clearances from Custom Medical Devices Intl., Inc.

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K800862 — 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.1980-05-30
K800864 — STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE1980-05-30

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.