Cleared Traditional

K140768 - TYPE I BRILLIANT INTRODUCER KIT

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
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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.

View all Lepu Medical Technology (Bejing) Co., Ltd. devices

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
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 483
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K140768.
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NANOSTIM INTRODUCER KIT
K140793 · St. Jude Medical, Inc. · Dec 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · Merit Medical Systems, Inc. · Oct 2014
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · Cook, Inc. · Oct 2014
EDWARDS ESHEATH INTRODUCER SET
K141696 · Edwards Lifesciences · Sep 2014