Cleared Traditional

CUTTER PUREFLO PLUS IV FILTER

K872634 · Miles Laboratories, Inc. · General Hospital
Aug 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K872634 is an FDA 510(k) clearance for the CUTTER PUREFLO PLUS IV FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Miles Laboratories, Inc. (Berkeley, US). The FDA issued a Cleared decision on August 4, 1987, 29 days after receiving the submission on July 6, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K872634 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1987
Decision Date August 04, 1987
Days to Decision 29 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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