Cleared Traditional

DualCap IV Pole Strips(Disinfectant Caps for Male Luers)

K142399 · Catheter Connections, Inc. · General Hospital
Nov 2014
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K142399 is an FDA 510(k) clearance for the DualCap IV Pole Strips(Disinfectant Caps 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 November 19, 2014, 84 days after receiving the submission on August 27, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142399 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2014
Decision Date November 19, 2014
Days to Decision 84 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