Cleared Traditional

HEART CATH TRAY

K912052 · Medical Device Inspection Co., Inc. · General & Plastic Surgery
Aug 1991
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K912052 is an FDA 510(k) clearance for the HEART CATH TRAY, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on August 20, 1991, 103 days after receiving the submission on May 9, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K912052 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1991
Decision Date August 20, 1991
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSM — Tray, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — FSM Tray, Surgical, Instrument

All 75
INSTRUMENT TRAY LINER
K971217 · General Hospital Supply Corp. · May 1997
SINGLE USE INSTRUMENT TRAY
K962328 · Medcare Medical Group, Inc. · Aug 1996
SURGICAL INSTRUMENT TRAY
K944025 · Riley Medical, Inc. · Nov 1994
ARTHROSCOPY TRAY
K912106 · Medical Device Inspection Co., Inc. · Aug 1991
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
MAJOR BASIN TRAY
K912104 · Medical Device Inspection Co., Inc. · Aug 1991