Cleared Traditional

K131411 - COSEAL

K131411 is an FDA 510(k) clearance for COSEAL, manufactured by Jilin Coronado Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K131411 · Jilin Coronado Medical , Ltd. · Cardiovascular device
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Sep 2013
Decision
134d
Days
Class 2
Risk

K131411 is an FDA 510(k) clearance for the COSEAL. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Jilin Coronado Medical , Ltd. (Jilin, CN). The FDA issued a Cleared decision on September 26, 2013 after a review of 134 days - within the typical 510(k) review window.

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: 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 Jilin Coronado Medical , Ltd. devices

FDA 510(k) Submission Details - K131411

510(k) Number K131411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2013
Decision Date September 26, 2013
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
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 Peers - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K131411.
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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · Edwards Lifesciences, LLC · Sep 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · Boston Scientific Corporation · Jun 2013
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012