Cleared Traditional

HOOD BIFURCATED T-TUBE

K864533 · Hood Laboratories · Anesthesiology
Mar 1987
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K864533 is an FDA 510(k) clearance for the HOOD BIFURCATED T-TUBE, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 9, 1987, 111 days after receiving the submission on November 18, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K864533 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1986
Decision Date March 09, 1987
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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