Cleared Special

CATHETER CONNECTIONS' DUALCAP DUO

K112985 · Catheter Connections, Inc. · General Hospital
Nov 2011
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K112985 is an FDA 510(k) clearance for the CATHETER CONNECTIONS' DUALCAP DUO, 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 November 9, 2011, 34 days after receiving the submission on October 6, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K112985 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2011
Decision Date November 09, 2011
Days to Decision 34 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