Cleared Special

Destino Reach

K151951 · Oscor, Inc. · Cardiovascular
Sep 2015
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K151951 is an FDA 510(k) clearance for the Destino Reach, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on September 22, 2015, 69 days after receiving the submission on July 15, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K151951 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2015
Decision Date September 22, 2015
Days to Decision 69 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340