Cleared Traditional

K172099 - Shoocin Introducer Kit

K172099 is an FDA 510(k) clearance for Shoocin Introducer Kit, manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K172099 · Lepu Medical Technology (Beijing) Co., Ltd. · Cardiovascular device
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Oct 2017
Decision
86d
Days
Class 2
Risk

K172099 is an FDA 510(k) clearance for the Shoocin Introducer Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Lepu Medical Technology (Beijing) Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 5, 2017 after a review of 86 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 Lepu Medical Technology (Beijing) Co., Ltd. devices

FDA 510(k) Submission Details - K172099

510(k) Number K172099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2017
Decision Date October 05, 2017
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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 Consultant

FDA Regulatory and Quality Systems Consultant
Arthur Goddard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 659
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K172099.
Performer Introducer
K173068 · Cook Incorporated · Nov 2017
D'Vill Introducer
K171206 · NuMED, Inc. · Oct 2017
R2P Destination Slender Guiding Sheath
K171491 · Terumo Medical Corporation · 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