Cleared Special

K030567 - MODIFICATION TO VASCULAR ARCHITECTS ASP...

K030567 is an FDA 510(k) clearance for MODIFICATION TO VASCULAR ARCHITECTS ASP..., manufactured by Vascular Architects, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCT cleared through the Special 510(k) pathway after a 28-day FDA review.

K030567 · Vascular Architects, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
28d
Days
Class 2
Risk

K030567 is an FDA 510(k) clearance for the MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPAN.... Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Vascular Architects, Inc. (San Jose, US). The FDA issued a Cleared decision on March 24, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3720 - the FDA general and plastic surgery device 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 Vascular Architects, Inc. devices

FDA 510(k) Submission Details - K030567

510(k) Number K030567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date March 24, 2003
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

JCT Device Classification - Class 2, Special Controls

Product Code JCT Prosthesis, Tracheal, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCT Prosthesis, Tracheal, Expandable

All 30
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K030567.
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VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc. · Mar 2003
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · W.L. Gore & Associates, Inc. · Dec 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · Boston Scientific Scimed, Inc. · Jul 2002