Cleared Traditional

K813587 - DISPOSABLE THORACIC CATHETER
(FDA 510(k) Clearance)

K813587 · Texas Medical Products, Inc. · General & Plastic Surgery

Jan 1982

Decision

15d

Days

Class 1

Risk

K813587 is an FDA 510(k) clearance for the DISPOSABLE THORACIC CATHETER, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982, 15 days after receiving the submission on December 28, 1981. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K813587 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 1981
Decision Date	January 12, 1982
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—