Cleared Traditional

VIAL VENT FILTER

K942275 · Gelman Sciences, Inc. · General Hospital
Jul 1994
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K942275 is an FDA 510(k) clearance for the VIAL VENT FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 26, 1994, 77 days after receiving the submission on May 10, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K942275 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1994
Decision Date July 26, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

Similar Devices — FPB Filter, Infusion Line

All 97
Filter Needle for Single Use
K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
Cathivex ?GV filter units
K143583 · Merck Millipore , Ltd. · Aug 2015
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
ARTERIA BLOOD FILTER
K021293 · Arteria Medical Science, Inc. · Aug 2002
PALL SUPOR AEF FILTER
K993379 · Pall Corp. · Dec 1999
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998