Cleared Traditional

THORA-CATH

K941232 · Gesco Intl., Inc. · General Hospital
May 1994
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K941232 is an FDA 510(k) clearance for the THORA-CATH, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on May 11, 1994, 57 days after receiving the submission on March 15, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K941232 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1994
Decision Date May 11, 1994
Days to Decision 57 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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