Cleared Abbreviated

K031041 - FLUENCY TRACHEOBRONCHIAL STENT GRAFT (FDA 510(k) Clearance)

K031041 · Bard Peripheral Vascular · General & Plastic Surgery device

Jun 2003

Decision

79d

Days

Class 2

Risk

K031041 is an FDA 510(k) clearance for the FLUENCY TRACHEOBRONCHIAL STENT GRAFT. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).

Submitted by Bard Peripheral Vascular (Tempe, US). The FDA issued a Cleared decision on June 19, 2003, 79 days after receiving the submission on April 1, 2003.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number	K031041 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2003
Decision Date	June 19, 2003
Days to Decision	79 days
Submission Type	Abbreviated
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF