Cleared Traditional

BD INSYTE AUTOGUARD BC

K110443 · Becton, Dickinson & CO · General Hospital
Jul 2011
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K110443 is an FDA 510(k) clearance for the BD INSYTE AUTOGUARD BC, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton, Dickinson & CO (Sandy, US). The FDA issued a Cleared decision on July 19, 2011, 153 days after receiving the submission on February 16, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K110443 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2011
Decision Date July 19, 2011
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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