Cleared Traditional

Sterile High-pressure Angiographic Syringes for Single-use

K192657 · Shenzhen Boon Medical Supply Co., Ltd. · General Hospital
Aug 2020
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K192657 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 August 7, 2020, 317 days after receiving the submission on September 25, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K192657 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2019
Decision Date August 07, 2020
Days to Decision 317 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

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