Cleared Traditional

MEADOX EXXCEL EPTFE VASCULAR GRAFT

K962433 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular
Mar 1997
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K962433 is an FDA 510(k) clearance for the MEADOX EXXCEL EPTFE VASCULAR GRAFT, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on March 17, 1997, 266 days after receiving the submission on June 24, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K962433 FDA.gov
FDA Decision Cleared ST
Date Received June 24, 1996
Decision Date March 17, 1997
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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