Cleared Special

CATHETER CONNECTIONS' DUALCAP SOLO

K113842 · Catheter Connections, Inc. · General Hospital
Jan 2012
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K113842 is an FDA 510(k) clearance for the CATHETER CONNECTIONS' DUALCAP SOLO, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Catheter Connections, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 27, 2012, 30 days after receiving the submission on December 28, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K113842 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2011
Decision Date January 27, 2012
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QBP — Cap, Device Disinfectant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440
Definition Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time