Cleared Traditional

FLOWEASE [SUBCUTANEOUS] INFUSION SET

K121092 · Baxter Healthcare Corp · General Hospital
Jun 2012
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K121092 is an FDA 510(k) clearance for the FLOWEASE [SUBCUTANEOUS] INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Baxter Healthcare Corp (Westlake Village, US). The FDA issued a Cleared decision on June 29, 2012, 80 days after receiving the submission on April 10, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K121092 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2012
Decision Date June 29, 2012
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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