Cleared Traditional

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

K172995 · Terumo Medical Corporation · Cardiovascular
Nov 2017
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K172995 is an FDA 510(k) clearance for the Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on November 21, 2017, 55 days after receiving the submission on September 27, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K172995 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2017
Decision Date November 21, 2017
Days to Decision 55 days
Submission Type Traditional
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