BD Centro Vena Acute Central Line (7 French Dual Lumen)— 510(k) K200266

Name: FDA 510(k) clearance K200266
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Substantially Equivalent

Bard Access Systems, Inc. (Bard Has Joined Bd)

FDA 510(k) clearance K200266 for BD Centro Vena Acute Central Line (7 French Dual Lumen), Substantially Equivalent on 2020-04-07. Applicant: Bard Access Systems, Inc. (Bard Has Joined Bd). Device class: 2.

Clearance details

Applicant: Bard Access Systems, Inc. (Bard Has Joined Bd)
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2020-02-03
Decision date: 2020-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

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K261041 — ClearSafe Closed System2026-07-10
K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

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K190855 — BD Acute Central Line2019-11-01

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.