510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061626Substantially Equivalent

Vasoring* Vrc Vascular Ring Connector

Sunwei Tech Co., Ltd., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061626 is the FDA 510(k) clearance record for VASORING* VRC VASCULAR RING CONNECTOR, a class II device, cleared for Sunwei Tech Co. , Ltd. on under FDA product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter). FDA records list one 510(k) clearance for Sunwei Tech Co. , Ltd. As of , FDA records show no recalls naming K061626.

Clearance record

Decision date
Received
(115 days to decision)
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Sunwei Tech Co. , Ltd. 7128 Staffordshire St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSY

Trailing 12 months
1 clearance under product code DSY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260