Cleared Special

K050832 - FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

K050832 is the FDA 510(k) clearance for FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT by Bard Peripheral Vascular, Inc.. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Special 510(k) pathway after a 97-day FDA review.

K050832 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
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Jul 2005
Decision
97d
Days
Class 2
Risk

K050832 is an FDA 510(k) clearance for the FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on July 7, 2005 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K050832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date July 07, 2005
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 28
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K050832.
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ATRIUM ICAST COVERED STENT
K050814 · Atrium Medical Corp. · May 2005
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · Atrium Medical Corp. · Sep 2004
VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc. · Mar 2003