FDA 510(k)

AN3500 WORTH DRAIN

K-Number: K872457 · 1987-07-21

Decision Date1987-07-21

Product CodeGBS

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AN3500 WORTH DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is H.W. Andersen Products, Inc.. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872457. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AN3500 WORTH DRAIN?

AN3500 WORTH DRAIN is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is H.W. Andersen Products, Inc.. The 510(k) number is K872457.

When did AN3500 WORTH DRAIN receive FDA 510(k) clearance?

AN3500 WORTH DRAIN received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872457.

Who is the listed applicant for AN3500 WORTH DRAIN?

The FDA 510(k) record lists H.W. Andersen Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AN3500 WORTH DRAIN?

The FDA product code for AN3500 WORTH DRAIN is GBS.

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Other records listing H.W. Andersen Products, Inc. as applicant

K935688AN-10S ANDERSEN TUBE WITH STYLET K872458AN3200 DOUBILET DRAIN K872460AN3000 MAHONEY DRAIN K872459AN3100 MULHOLLAND DRAIN

Related Devices (Code: GBS)

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.