Cleared Special

CardioCel 3D (K170951) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170951 · Admedus Regen Pty, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
28d
Days
Class 2
Risk

K170951 is an FDA 510(k) clearance for the CardioCel 3D. Classified as Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ), Class II - Special Controls.

Submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on April 28, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Admedus Regen Pty, Ltd. devices

Submission Details

510(k) Number K170951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date April 28, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PSQ Intracardiac Patch Or Pledget, Biologically Derived
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.
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 - PSQ Intracardiac Patch Or Pledget, Biologically Derived

All 10
Devices cleared under the same product code (PSQ) and FDA review panel - the closest regulatory comparables to K170951.
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