INSTAVAC II

K934976 · Aeros Instruments, Inc. · BTA · May 2, 1994 · General, Plastic Surgery

Device Facts

Record IDK934976
Device NameINSTAVAC II
ApplicantAeros Instruments, Inc.
Product CodeBTA · General, Plastic Surgery
Decision DateMay 2, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4780
Device ClassClass 2

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Innolitics

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