STOPCOCKS— 510(k) K851986

Name: FDA 510(k) clearance K851986
Creator: U.S. Food and Drug Administration
Published: 1985-05-23

Substantially Equivalent

Transamerica Delaval, Inc.

FDA 510(k) clearance K851986 for STOPCOCKS, Substantially Equivalent on 1985-05-23. Applicant: Transamerica Delaval, Inc.. Device class: 2.

Clearance details

Applicant: Transamerica Delaval, Inc.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1985-05-07
Decision date: 1985-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pasadena, CA, US

Download summary PDF View on FDA.gov ↗

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K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
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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 Transamerica Delaval, Inc.

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K853996 — DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE1986-05-07
K851989 — DOME, DISPOSABLE, STERILE1985-08-19
K851987 — FLUSH DEVICE, AUTOMATIC1985-08-16
K851988 — ADMINISTRATION SET1985-08-16
K833171 — MONITORING KIT1984-09-06

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.