Cleared Traditional

K061626 - VASORING* VRC VASCULAR RING CONNECTOR

K061626 is an FDA 510(k) clearance for VASORING* VRC VASCULAR RING CONNECTOR, manufactured by Sunwei Tech Co. , Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K061626 · Sunwei Tech Co. , Ltd. · Cardiovascular device
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Oct 2006
Decision
115d
Days
Class 2
Risk

K061626 is an FDA 510(k) clearance for the VASORING* VRC VASCULAR RING CONNECTOR. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Sunwei Tech Co. , Ltd. (Houston, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 Sunwei Tech Co. , Ltd. devices

FDA 510(k) Submission Details - K061626

510(k) Number K061626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2006
Decision Date October 05, 2006
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 143
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K061626.
VASCUTEK BRANCHED GELWEAVE
K090987 · Vascutek, Ltd. · Jun 2009
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · Atrium Medical Corp. · Aug 2007
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006
ATRIUM FLIXENE GRAFT
K060124 · Atrium Medical Corp. · Mar 2006
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142 · Vascutek, Ltd. · Feb 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006