Cleared Traditional

Altaviz Needle Kit

K222681 · Altaviz, LLC · General Hospital

Dec 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K222681 is an FDA 510(k) clearance for the Altaviz Needle Kit, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Altaviz, LLC (Irvine, US). The FDA issued a Cleared decision on December 5, 2022, 90 days after receiving the submission on September 6, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K222681 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2022
Decision Date	December 05, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF