CATHETER CONNECTIONS DUALCAP SOLO— 510(k) K123065

Name: FDA 510(k) clearance K123065
Creator: U.S. Food and Drug Administration
Published: 2012-12-14

Substantially Equivalent

Catheter Connections, Inc.

FDA 510(k) clearance K123065 for CATHETER CONNECTIONS DUALCAP SOLO, Substantially Equivalent on 2012-12-14. Applicant: Catheter Connections, Inc.. Device class: 2.

Clearance details

Applicant: Catheter Connections, Inc.
Product code: Code QBP
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2012-10-01
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Catheter Connections, Inc.

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K142806 — DualCap2015-05-22
K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers)2014-11-19
K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS2013-01-22
K113842 — CATHETER CONNECTIONS' DUALCAP SOLO2012-01-27
K112985 — CATHETER CONNECTIONS' DUALCAP DUO2011-11-09

Recalls naming K123065

K-number listed on FDA's recall record

Z-2595-2014 — DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.Class II·Terminated·Catheter Connections, Inc.·20140805

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123065.

Data sourced from openFDA. This site is unofficial and independent of the FDA.