Cleared Traditional

INTERCOSTAL LOCKABLE-DIRECTABLE PORT

K011349 · Medcanica, Inc. · Cardiovascular
Oct 2001
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K011349 is an FDA 510(k) clearance for the INTERCOSTAL LOCKABLE-DIRECTABLE PORT, a Trocar (Class II — Special Controls, product code DRC), submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on October 5, 2001, 156 days after receiving the submission on May 2, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K011349 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2001
Decision Date October 05, 2001
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRC — Trocar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1390

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