Cleared Traditional

CATHETER CONNECTIONS DUALCAP

K093229 · Catheter Connections, Inc. · General Hospital
Apr 2010
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K093229 is an FDA 510(k) clearance for the CATHETER CONNECTIONS DUALCAP, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Catheter Connections, Inc. (Park City, US). The FDA issued a Cleared decision on April 8, 2010, 176 days after receiving the submission on October 14, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K093229 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2009
Decision Date April 08, 2010
Days to Decision 176 days
Submission Type Traditional
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