Cleared Traditional

CLYDE (TM) FILTRATION SYSTEM

K864113 · Arbor Technologies, Inc. · General Hospital
Feb 1987
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K864113 is an FDA 510(k) clearance for the CLYDE (TM) FILTRATION SYSTEM, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on February 4, 1987, 106 days after receiving the submission on October 21, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K864113 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1986
Decision Date February 04, 1987
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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