Cleared Traditional

AMSINO SUCTION CATHETER

K973199 · Amsino Intl., Inc. · Anesthesiology
Sep 1997
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K973199 is an FDA 510(k) clearance for the AMSINO SUCTION CATHETER, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on September 10, 1997, 15 days after receiving the submission on August 26, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number K973199 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1997
Decision Date September 10, 1997
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K961707 · Sorenson Critical Care · Mar 1997