510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082439Substantially Equivalent

Disposable Angiographic Syringe, Model(s) CT-200-Ne, CT-200-Ma, CT-200+200-Ma, CT-200-Lf, CT -100-Ne, CT-200Ne, CT-50+Ct

Shandong Weigao Medical Polymer Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082439 is the FDA 510(k) clearance record for DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT, a class II device, cleared for Shandong Weigao Medical Polymer Co., Ltd. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list one 510(k) clearance for Shandong Weigao Medical Polymer Co., Ltd. As of , FDA records show no recalls naming K082439.

Clearance record

Decision date
Received
(210 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Shandong Weigao Medical Polymer Co., Ltd. Suite 8d, # 19, Ln. 999, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXT

Trailing 12 months
7 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261