Cleared Traditional

AN3000 MAHONEY DRAIN

K872460 · H.W. Andersen Products, Inc. · General & Plastic Surgery
Jul 1987
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K872460 is an FDA 510(k) clearance for the AN3000 MAHONEY DRAIN, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by H.W. Andersen Products, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on July 23, 1987, 30 days after receiving the submission on June 23, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K872460 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1987
Decision Date July 23, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GBS — Catheter, Ventricular, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200

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