Cleared Traditional

K142359 - Vasc Band hemostat

K142359 is an FDA 510(k) clearance for Vasc Band hemostat, manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K142359 · Lepu Medical Technology (Beijing) Co., Ltd. · Cardiovascular device
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Oct 2014
Decision
59d
Days
Class 2
Risk

K142359 is an FDA 510(k) clearance for the Vasc Band hemostat. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Lepu Medical Technology (Beijing) Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 23, 2014 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 - K142359

510(k) Number K142359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date October 23, 2014
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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

Vascular Solutions, Inc.
Erin Badali

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 - DXC Clamp, Vascular

All 189
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K142359.
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