Medical Device Manufacturer · CN , Zibo

Shinva Ande Healthcare Apparatus Co., Ltd. - FDA 510(k) Cleared Devic...

6 submissions · 6 cleared · Since 2017

Recent clearances: Closed System Transfer Device, Disposable Sterile Syringe with permanently attached needle, Disposable Sterile Syringe with Safety Needle

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shinva Ande Healthcare Apparatus Co., Ltd. General Hospital ✕

5 devices

1-5 of 5

Cleared Nov 23, 2022

Closed System Transfer Device

General Hospital · 904d

Cleared Oct 07, 2022

Disposable Sterile Syringe with permanently attached needle

General Hospital · 274d

Cleared Mar 01, 2022

Disposable Sterile Syringe with Safety Needle

General Hospital · 293d

Cleared Jul 23, 2021

Disposable IV catheter

General Hospital · 361d

Cleared May 31, 2017

Infusion Set for Single Use

General Hospital · 254d