Cleared Traditional

Unity Subcutaneous Delivery System for Remodulin

K190182 · DEKA Research & Development · General Hospital
May 2019
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K190182 is an FDA 510(k) clearance for the Unity Subcutaneous Delivery System for Remodulin, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by DEKA Research & Development (Manchester, US). The FDA issued a Cleared decision on May 6, 2019, 94 days after receiving the submission on February 1, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K190182 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date May 06, 2019
Days to Decision 94 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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