Cleared Traditional

AMSafe NeuFlo Needleless Connector

K220267 · Amsino International, Inc. · General Hospital
Oct 2022
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K220267 is an FDA 510(k) clearance for the AMSafe NeuFlo Needleless Connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 7, 2022, 249 days after receiving the submission on January 31, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K220267 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2022
Decision Date October 07, 2022
Days to Decision 249 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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