Cleared Traditional

Sterile High-pressure Angiographic Syringes for Single-use

K211564 · Shenzhen Boon Medical Supply Co., Ltd. · General Hospital
Oct 2021
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K211564 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for Single-use, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Shenzhen Boon Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 19, 2021, 152 days after receiving the submission on May 20, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K211564 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2021
Decision Date October 19, 2021
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

Similar Devices — DXT Injector And Syringe, Angiographic

All 205
Extension tube
K251788 · Zhuhai DR Medical Instruments Co., Ltd. · Mar 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
K252891 · Bayer Medical Care, Inc. · Feb 2026
High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2024