Cleared Traditional

K171491 - R2P Destination Slender Guiding Sheath

K171491 is an FDA 510(k) clearance for R2P Destination Slender Guiding Sheath, manufactured by Terumo Medical Corporation. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K171491 · Terumo Medical Corporation · Cardiovascular device
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Oct 2017
Decision
136d
Days
Class 2
Risk

K171491 is an FDA 510(k) clearance for the R2P Destination Slender Guiding Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on October 5, 2017 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo Medical Corporation devices

FDA 510(k) Submission Details - K171491

510(k) Number K171491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date October 05, 2017
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 433
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K171491.
Peel-Away Introducer Set
K173685 · Cook Incorporated · Dec 2017
Performer Introducer
K173068 · Cook Incorporated · Nov 2017
D'Vill Introducer
K171206 · NuMED, Inc. · Oct 2017
Peel-Away Introducer Set
K170020 · Cook Incorporated · Sep 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · Merit Medical Systems, Inc. · Sep 2017
Liver Access and Biopsy Sets
K171853 · Cook Incorporated · Aug 2017