Cleared Traditional

FAST1? Intraosseous Infusion System; FASTResponder? Sternal Intraosseous Device

K180588 · Teleflex Medical · General Hospital

Apr 2018

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K180588 is an FDA 510(k) clearance for the FAST1? Intraosseous Infusion System; FASTResponder? Sternal Intraosseous Device, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on April 17, 2018, 42 days after receiving the submission on March 6, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K180588 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2018
Decision Date	April 17, 2018
Days to Decision	42 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF