Cleared Special

CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS

K123967 · Catheter Connections, Inc. · General Hospital
Jan 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K123967 is an FDA 510(k) clearance for the CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS, 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 22, 2013, 27 days after receiving the submission on December 26, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K123967 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date January 22, 2013
Days to Decision 27 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