Cleared Special

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES

K071222 · Baxter Healthcare Corp · General Hospital
May 2007
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K071222 is an FDA 510(k) clearance for the INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 25, 2007, 23 days after receiving the submission on May 2, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K071222 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2007
Decision Date May 25, 2007
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEB — Pump, Infusion, Elastomeric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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