Cleared Traditional

LOW VOLUME MULTIPORT

K943770 · B. Braun of America, Inc. · General Hospital
Apr 1995
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K943770 is an FDA 510(k) clearance for the LOW VOLUME MULTIPORT, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 10, 1995, 251 days after receiving the submission on August 2, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K943770 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1994
Decision Date April 10, 1995
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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