Cleared Traditional

LEOCOR GUIDING CATHETER

K911270 · Leocor, Inc. · Cardiovascular

Jan 1992

Decision

301d

Days

Class 2

Risk

About This 510(k) Submission

K911270 is an FDA 510(k) clearance for the LEOCOR GUIDING CATHETER, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Leocor, Inc. (Houston, US). The FDA issued a Cleared decision on January 17, 1992, 301 days after receiving the submission on March 22, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K911270 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1991
Decision Date	January 17, 1992
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—