Cleared Traditional

TRUMPET VALVE

K911415 · B. Braun of America, Inc. · General Hospital
Jun 1991
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K911415 is an FDA 510(k) clearance for the TRUMPET VALVE, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 3, 1991, 63 days after receiving the submission on April 1, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K911415 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1991
Decision Date June 03, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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