Cleared Traditional

K130872 - CARDIOCEL

K130872 is an FDA 510(k) clearance for CARDIOCEL, manufactured by Celxcel Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K130872 · Celxcel Pty, Ltd. · Cardiovascular device
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Jan 2014
Decision
307d
Days
Class 2
Risk

K130872 is an FDA 510(k) clearance for the CARDIOCEL. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Celxcel Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on January 30, 2014 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Celxcel Pty, Ltd. devices

FDA 510(k) Submission Details - K130872

510(k) Number K130872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date January 30, 2014
Days to Decision 307 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
182d slower than avg
Panel avg: 125d · This submission: 307d
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 51
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