Cleared Traditional

Perfusor? Space Syringe Infusion Pump System

K172831 · B.Braun Medical, Inc. · General Hospital
Jun 2018
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K172831 is an FDA 510(k) clearance for the Perfusor? Space Syringe Infusion Pump System, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 12, 2018, 267 days after receiving the submission on September 18, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K172831 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2017
Decision Date June 12, 2018
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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