Cleared Traditional

ADDITIVE CAP

K111217 · Baxter Healthcare Corp · General Hospital
Jun 2011
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K111217 is an FDA 510(k) clearance for the ADDITIVE CAP, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on June 14, 2011, 43 days after receiving the submission on May 2, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K111217 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2011
Decision Date June 14, 2011
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5025

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