Cleared Traditional

ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR

K893394 · Haemonetics Corp. · Anesthesiology
Oct 1989
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K893394 is an FDA 510(k) clearance for the ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on October 19, 1989, 171 days after receiving the submission on May 1, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K893394 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1989
Decision Date October 19, 1989
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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