Aprima Smartesis Centesis Pump
K号: K161002 · 2016-09-28
广告
器械摘要
Aprima Smartesis Centesis Pump is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K161002. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aprima Smartesis Centesis Pump?
Aprima Smartesis Centesis Pump is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Cook Incorporated. The 510(k) number is K161002.
When did Aprima Smartesis Centesis Pump receive FDA 510(k) clearance?
Aprima Smartesis Centesis Pump received FDA 510(k) clearance on 2016-09-28, under 510(k) number K161002.
Who is the listed applicant for Aprima Smartesis Centesis Pump?
The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aprima Smartesis Centesis Pump?
The FDA product code for Aprima Smartesis Centesis Pump is BTA.
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Cook Incorporated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。
K233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo IntroducerK191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
相关器械（代码：BTA）
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。
K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.
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。
广告