免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Squirt Fluid Delivery System

K号: K162777 · 2016-10-31

申请人Merit Medical Systems, Inc.
决定日期2016-10-31
产品代码QEY
咨询委员会CV
决定Substantially Equivalent

器械摘要

Squirt Fluid Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K162777. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Squirt Fluid Delivery System?

Squirt Fluid Delivery System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K162777.

When did Squirt Fluid Delivery System receive FDA 510(k) clearance?

Squirt Fluid Delivery System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K162777.

Who is the listed applicant for Squirt Fluid Delivery System?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Squirt Fluid Delivery System?

The FDA product code for Squirt Fluid Delivery System is QEY.

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

列明Merit Medical Systems, Inc.为申报人的其他记录

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。

K261310FlexTract Deflectable-Rotational Dilator Sheath SetK262086PreludeSYNC™ Radial Compression DeviceK254073StatSeal DiscK251802STAR RF Ablation SystemK252892SCOUT MD Surgical Guidance SystemK250853Merit Syringe

查看所有 66 个设备 →

相关器械（代码：QEY）

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。

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑