Cleared Traditional

Lockbox for Perfusor Space PCA Infusion Pump

K173531 · B.Braun Medical, Inc. · General Hospital
Aug 2018
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K173531 is an FDA 510(k) clearance for the Lockbox for Perfusor Space PCA Infusion Pump, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 2, 2018, 260 days after receiving the submission on November 15, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K173531 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2017
Decision Date August 02, 2018
Days to Decision 260 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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