Cleared Traditional

SYVEKEXCEL

K053300 · Marine Polymer Technologies, Inc. · Cardiovascular
Mar 2006
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K053300 is an FDA 510(k) clearance for the SYVEKEXCEL, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on March 28, 2006, 123 days after receiving the submission on November 25, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K053300 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2005
Decision Date March 28, 2006
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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