Leocor Guiding Catheter

FDA 510(k) K911270 · Leocor, Inc.

Substantially Equivalent

510(k) numberK911270

Submission

Device name
Leocor Guiding Catheter
Applicant
Leocor, Inc.
Houston, TX, US
Received
March 22, 1991
Decision date
January 17, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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K233975Zoom 6F Insert CathetersDQO · Traditional Imperative Care, Inc.04/02/2024SE
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Questions and answers

When was Leocor Guiding Catheter cleared by the FDA?

Leocor Guiding Catheter (K911270) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 301 days after the submission was received.

What is the product code of K911270?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.