Cleared Special

K162579 - VascuCel

K162579 is an FDA 510(k) clearance for VascuCel, manufactured by Admedus Regen Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K162579 · Admedus Regen Pty, Ltd. · Cardiovascular device
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Oct 2016
Decision
29d
Days
Class 2
Risk

K162579 is an FDA 510(k) clearance for the VascuCel. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on October 14, 2016 after a review of 29 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

FDA 510(k) Submission Details - K162579

510(k) Number K162579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2016
Decision Date October 14, 2016
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 71
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