Cleared Special

K050832 - FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

K050832 is an FDA 510(k) clearance for FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT, manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 General & Plastic Surgery device with 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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K050832

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
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 44
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K050832 · FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
Download PDF FDA Summary Bard Peripheral Vascu…