Cleared Traditional

Orbit Infusion Set

K150921 · Ypsomed AG · General Hospital
Apr 2016
Decision
372d
Days
Class 2
Risk

About This 510(k) Submission

K150921 is an FDA 510(k) clearance for the Orbit Infusion Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on April 12, 2016, 372 days after receiving the submission on April 6, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K150921 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2015
Decision Date April 12, 2016
Days to Decision 372 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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