Cleared Traditional

PULM O2 SUCTION CATHETER TRAYS

K953226 · Premium Plastics, Inc. · Anesthesiology
Aug 1995
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K953226 is an FDA 510(k) clearance for the PULM O2 SUCTION CATHETER TRAYS, a Catheters, Suction, Tracheobronchial (Class I — General Controls, product code BSY), submitted by Premium Plastics, Inc. (Chicago, US). The FDA issued a Cleared decision on August 8, 1995, 33 days after receiving the submission on July 6, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6810.

Submission Details

510(k) Number K953226 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1995
Decision Date August 08, 1995
Days to Decision 33 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