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FDA 510(k)

高压注射器；压力连接管；快速填充管；针头；转移管

K号: K253048 · 2026-04-16

申请人Shenzhen Maiwei Biotech Co., Ltd.
决定日期2026-04-16
产品代码DXT
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253048. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. The 510(k) number is K253048.

When did High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube receive FDA 510(k) clearance?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253048.

Who is the listed applicant for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA 510(k) record lists Shenzhen Maiwei Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is DXT.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：DXT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252652用于电力注射器的配套一次性注射器（900103T）；用于电力注射器的配套一次性注射器（900103H）；用于电力注射器的配套一次性注射器（801800H）；用于电力注射器的配套一次性注射器（800099T）；用于电力注射器的配套一次性注射器（800099H）；用于电力注射器的配套一次性注射器（800096T）；用于电力注射器的配套一次性注射器（800096H）；一次性注射器配套Fortis Biosolutions Company LimitedK252638VeraPro S100 多功能注射器（018808）；VeraPro S100 LV1 低粘度一次性注射器（018811）；VeraPro AMT 自动分路器和传感器（018814）；VeraPro AngioTouch FLX165 手控器套件（018806）；VeraPro AngioTouch HiFi165 手控器套件（018804）Acist Medical Systems, Inc.K252653ACIST Pro 诊断系统 (019304)；处理单元床架；AngioTouch 模块；ACIST Pro 手推车；单探头电缆；三探头电缆Acist Medical Systems, Inc.K251788扩展管Zhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR 注射系统及 MR 注射系统注射器套件；MEDRAD ISI2 模块（ISI2）Bayer Medical Care, Inc.K244038高压软管Shandong Int Medical Instruments Co., Ltd.

官方来源

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