Cleared Traditional

Mini Spike Plus 6/8R

K201469 · B.Braun Medical, Inc. · General Hospital
Dec 2020
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K201469 is an FDA 510(k) clearance for the Mini Spike Plus 6/8R, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on December 9, 2020, 189 days after receiving the submission on June 3, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K201469 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2020
Decision Date December 09, 2020
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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