Cleared Traditional

CATCO THORACIC CATHETER

K945728 · Catco Medical, Inc. · General Hospital
May 1995
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K945728 is an FDA 510(k) clearance for the CATCO THORACIC CATHETER, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 23, 1995, 182 days after receiving the submission on November 22, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K945728 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1994
Decision Date May 23, 1995
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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