Cleared Traditional

VASCULAR PROBE, VASCULAR PROBE ES

K130896 · Synovis Life Technologies, Inc. · Cardiovascular
Apr 2013
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K130896 is an FDA 510(k) clearance for the VASCULAR PROBE, VASCULAR PROBE ES, a Dilator, Vessel, Surgical (Class II — Special Controls, product code DWP), submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 24, 2013, 23 days after receiving the submission on April 1, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4475.

Submission Details

510(k) Number K130896 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2013
Decision Date April 24, 2013
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWP — Dilator, Vessel, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4475

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