Cleared Special

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

K113227 · Baxter Healthcare Corp · General Hospital
Dec 2011
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K113227 is an FDA 510(k) clearance for the NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on December 8, 2011, 37 days after receiving the submission on November 1, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K113227 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2011
Decision Date December 08, 2011
Days to Decision 37 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440