Cleared Traditional

AIRWAY CONNECTOR WITH FLEX TUBE

K942392 · Mallinckrodt Medical · Anesthesiology
Aug 1994
Decision
95d
Days
Class 1
Risk

About This 510(k) Submission

K942392 is an FDA 510(k) clearance for the AIRWAY CONNECTOR WITH FLEX TUBE, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on August 22, 1994, 95 days after receiving the submission on May 19, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number K942392 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1994
Decision Date August 22, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810

Similar Devices — BZA Connector, Airway (extension)

All 93
TRACH-ASSIST
K083702 · Mergenet Medical · Mar 2009
SURELOC CIRCUIT CONNECTOR
K954383 · Polamedco, Inc. · Dec 1995
DISPOSABLE FLEX TUBE
K954197 · Engstrom Medical · Oct 1995
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
K953786 · Unicor, Inc. · Sep 1995
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
K952824 · Intertex Medical, Inc. · Jul 1995
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
K951345 · Catheter Research, Inc. · Apr 1995

More from Mallinckrodt Medical

View all
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · BTR · Oct 2008
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · JOH · Jun 2005
HI-CARE CLOSED SUCTION SYSTEM
K972258 · BSY · Dec 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · JOH · Sep 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · JOH · Jun 1997