Cleared Traditional

IV ADMINISTRATION SET

K871908 · Travenol Laboratories, S.A. · General Hospital
Jul 1987
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K871908 is an FDA 510(k) clearance for the IV ADMINISTRATION SET, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on July 27, 1987, 73 days after receiving the submission on May 15, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K871908 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1987
Decision Date July 27, 1987
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code BRZ — Set, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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