Cleared Traditional

R2P Destination Slender Guiding Sheath

K193125 · Terumo Medical Corporation · Cardiovascular
Jan 2020
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K193125 is an FDA 510(k) clearance for the R2P Destination Slender 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 January 6, 2020, 55 days after receiving the submission on November 12, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K193125 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2019
Decision Date January 06, 2020
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