FDA 510(k)

Option ELITE 下腔静脉滤过系统 (352506070E 352506100E)

K号: K242612 · 2024-09-10

决定日期2024-09-10

产品代码DTK

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

Option ELITE Vena Cava Filter System (352506070E 352506100E) is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K242612. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Option ELITE Vena Cava Filter System (352506070E 352506100E)?

Option ELITE Vena Cava Filter System (352506070E 352506100E) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K242612.

When did Option ELITE Vena Cava Filter System (352506070E 352506100E) receive FDA 510(k) clearance?

Option ELITE Vena Cava Filter System (352506070E 352506100E) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K242612.

Who is the listed applicant for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

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

What is the FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

The FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E) is DTK.

列明Argon Medical Devices, 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。

K252795ZeniCore™ 自动活检仪器（863212100 / ZeniCore 自动活检设备 12ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863212130 / ZeniCore 自动活检设备 12ga x 13cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214100 / ZeniCore 自动活检设备 14ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214130 / ZeniCore 自动活检设备 14ga x 13cm 配同轴 K260028CLEANER® 真空血栓切除术系统，CLEANER® 真空吸引导管手柄，CLEANER® 真空吸引罐 K251318VariFuse 可调式输液导管 K253741V•Stick™ 血管通路套装 K241145TLAB®经静脉肝活检系统（TF-18C）K233909Cleaner™ Plus 18F 血栓切除术系统 - Cleaner™ Plus 18F 吸引导管，Cleaner™ Plus 18F 手柄带浸软线，Cleaner™ Plus 18F 吸引罐

查看所有 18 个设备 →

相关器械（代码：DTK）

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。

K240578VenaTech® LP 腔静脉滤器系统和 VenaTech® 可转换腔静脉滤器系统B.Braun Medical, Inc.K241507ALN 可选下腔静脉滤器 (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ 下腔静脉滤过系统 – 髂股部和颈静脉/锁骨下输送套件Bd K233680Celect Platinum 股静脉滤器套装 (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum 颈静脉滤器套装 (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum 股静脉和颈静脉滤器套装 (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip 股静脉滤器套装 (IGTCFS-65-1-FEM-TULIP); Günther Tulip 颈静脉滤器套装 (IGTCFS-65-1-JUG-TULIP); Günther Tulip 静脉滤器William Cook Europe Aps K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps K211875Cook Celect Platinum 股静脉途径下腔静脉滤器套装，Cook Celect Platinum 颈静脉途径下腔静脉滤器套装，Cook Celect Platinum 股静脉和颈静脉途径下腔静脉滤器套装William Cook Europe Aps

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。