Cleared Special

K193160 - Glidesheath Slender Tibial Pedal Kit

K193160 is the FDA 510(k) clearance for Glidesheath Slender Tibial Pedal Kit by Terumo Medical Coporation. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 18-day FDA review.

K193160 · Terumo Medical Coporation · Cardiovascular device
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Dec 2019
Decision
18d
Days
Class 2
Risk

K193160 is an FDA 510(k) clearance for the Glidesheath Slender Tibial Pedal Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Terumo Medical Coporation (Elkton, US). The FDA issued a Cleared decision on December 3, 2019 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Terumo Medical Coporation devices

Submission Details

510(k) Number K193160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2019
Decision Date December 03, 2019
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 391
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