SMARTSITE STOPCOCK— 510(k) K071400

Name: FDA 510(k) clearance K071400
Creator: U.S. Food and Drug Administration
Published: 2007-12-14

Substantially Equivalent

Cardinal Health, Alaris Products

FDA 510(k) clearance K071400 for SMARTSITE STOPCOCK, Substantially Equivalent on 2007-12-14. Applicant: Cardinal Health, Alaris Products. Device class: 2.

Clearance details

Applicant: Cardinal Health, Alaris Products
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2007-05-21
Decision date: 2007-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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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 Cardinal Health, Alaris Products

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K071108 — TEXIUM SYRINGE2007-05-24
K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS2006-07-26
K053049 — ALARIS SAFETY MALE LUER2006-01-12
K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD2005-12-23
K051641 — ALARIS SYSTEM PC UNIT, MODEL 80012005-10-20

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.