Cleared Traditional

GUIDEWIRE INTRODUCER SET

K915421 · B. Braun of America, Inc. · Cardiovascular
Feb 1992
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K915421 is an FDA 510(k) clearance for the GUIDEWIRE INTRODUCER SET, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 27, 1992, 87 days after receiving the submission on December 2, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K915421 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1991
Decision Date February 27, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340