Cleared Traditional

KENDALL MODU-VAC CLOSED SUCTION SYSTEM

K944251 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology
Sep 1994
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K944251 is an FDA 510(k) clearance for the KENDALL MODU-VAC CLOSED SUCTION SYSTEM, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on September 21, 1994, 21 days after receiving the submission on August 31, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number K944251 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1994
Decision Date September 21, 1994
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSY — Catheters, Suction, Tracheobronchial
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.6810

Similar Devices — BSY Catheters, Suction, Tracheobronchial

All 115
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
K031997 · Mallinckrodt Dar S.R.L. · Nov 2003
AMBU HAND POWER SUCTION PUMP
K992902 · Ambu, Inc. · Oct 1999
DUAL PURPOSE CLOSED CATHETER
K982945 · Spirit Medical Systems, Inc. · Sep 1998
SUCTION CATHETER
K981910 · Ni-Med, Inc. · Aug 1998
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
AMSINO SUCTION CATHETER
K973199 · Amsino Intl., Inc. · Sep 1997