Cleared Special

CATHETER CONNECTIONS DUALCAP SOLO

K123065 · Catheter Connections, Inc. · General Hospital
Dec 2012
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K123065 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 December 14, 2012, 74 days after receiving the submission on October 1, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K123065 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2012
Decision Date December 14, 2012
Days to Decision 74 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