Cleared Traditional

K152127 - CorMatrix Tyke (FDA 510(k) Clearance)

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

K152127 · Cormatrix Cardiovascular, Inc. · Cardiovascular device
Feb 2016
Decision
188d
Days
Class 2
Risk

K152127 is an FDA 510(k) clearance for the CorMatrix Tyke. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Cormatrix Cardiovascular, Inc. (Roswell, US). The FDA issued a Cleared decision on February 4, 2016 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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.

Submission Details

510(k) Number K152127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2015
Decision Date February 04, 2016
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 140d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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.