Cleared Traditional

GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ (K122980) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122980 · Terumo Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
76d
Days
Class 2
Risk

K122980 is an FDA 510(k) clearance for the GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16.... 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 December 11, 2012 after a review of 76 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Medical Corporation devices

Submission Details

510(k) Number K122980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date December 11, 2012
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 273
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122980.
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · W.L. Gore & Associates, Inc. · Nov 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012