Cleared Traditional

K011349 - INTERCOSTAL LOCKABLE-DIRECTABLE PORT (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011349 · Medcanica, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2001
Decision
156d
Days
Class 2
Risk

K011349 is an FDA 510(k) clearance for the INTERCOSTAL LOCKABLE-DIRECTABLE PORT. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on October 5, 2001 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcanica, Inc. devices

Submission Details

510(k) Number K011349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

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