Cleared Traditional

K152127 - CorMatrix Tyke

K152127 is an FDA 510(k) clearance for CorMatrix Tyke, manufactured by Cormatrix Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K152127 · Cormatrix Cardiovascular, Inc. · Cardiovascular device
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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.

View all Cormatrix Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K152127

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 72
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K152127.
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VascuCel
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K151865 · Aesculap, Inc. · Oct 2015
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447 · Synovis Life Technologies, Inc. · Jan 2015
VASCU-GUARD Peripheral Vascular Patch
K142461 · Synovis Life Technologies, Inc. · Nov 2014