Cleared Traditional

Single-use Sterile High-pressure Angiographic Syringes and Accessories

K241109 · Shenzhen Boon Medical Supply Co., Ltd. · General Hospital

Aug 2024

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K241109 is an FDA 510(k) clearance for the Single-use Sterile High-pressure Angiographic Syringes and Accessories, 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 August 22, 2024, 122 days after receiving the submission on April 22, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number	K241109 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2024
Decision Date	August 22, 2024
Days to Decision	122 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF