Cleared Traditional

K140768 - TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT

K140768 is an FDA 510(k) clearance for TYPE I BRILLIANT INTRODUCER KIT, manufactured by Lepu Medical Technology (Bejing) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K140768 · Lepu Medical Technology (Bejing) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
243d
Days
Class 2
Risk

K140768 is an FDA 510(k) clearance for the TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III B.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Lepu Medical Technology (Bejing) Co., Ltd. (South Euclid, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 243 days - an extended review 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: 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.

FDA 510(k) Submission Details - K140768

510(k) Number K140768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2014
Decision Date November 25, 2014
Days to Decision 243 days
Submission Type Traditional
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
118d slower than avg
Panel avg: 125d · This submission: 243d
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 689
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K140768.
ENDOPHYS PRESSURE SENSING SHEATH KIT
K141275 · Endophys, Inc. · Jan 2015
FIRSTSTIC N INTRODUCER
K141969 · Argon Medical Devices, Inc. · Dec 2014
NANOSTIM INTRODUCER KIT
K140793 · St. Jude Medical, Inc. · Dec 2014
GLIDESHEATH SLENDER
K142183 · Terumo Medical Corporation · Nov 2014
FlexCath Select Steerable Sheath (10 French)
K142684 · Medtronic Cryocath, LP · Nov 2014
EpiAccess System
K142245 · Epiep, Inc. · Oct 2014
K140768 · TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
Download PDF FDA Summary Lepu Medical Technolo…