Cleared Traditional

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

K020365 · 3t Medical Systems, LLC · Cardiovascular
May 2002
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K020365 is an FDA 510(k) clearance for the 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE, a Accessory Equipment, Cardiopulmonary Bypass (Class I — General Controls, product code KRI), submitted by 3t Medical Systems, LLC (Conifer, US). The FDA issued a Cleared decision on May 3, 2002, 88 days after receiving the submission on February 4, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4200.

Submission Details

510(k) Number K020365 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2002
Decision Date May 03, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code KRI — Accessory Equipment, Cardiopulmonary Bypass
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4200

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