FDA 510(k)

BASHIR 内窥镜导管参考编号 7201，BASHIR S-B 内窥镜导管，参考编号 7101

K号: K222095 · 2023-04-20

决定日期2023-04-20

产品代码QEY

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

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K222095. 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 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Thrombolex, Inc.. The 510(k) number is K222095.

When did BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 receive FDA 510(k) clearance?

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 received FDA 510(k) clearance on 2023-04-20, under 510(k) number K222095.

Who is the listed applicant for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

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

What is the FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101?

The FDA product code for BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 is QEY.

列明Thrombolex, 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。

K231653BASHIR™ .035 内窥镜导管，BASHIR™ S-B .035 内窥镜导管 K211061BASHIR 内窥镜导管（参考编号 7201），BASHIR Plus 10 内窥镜导管（参考编号 7210），BASHIR Plus 20 内窥镜导管（参考编号 7220），BASHIR Plus 30 内窥镜导管（参考编号 7230），BASHIR Plus 40 内窥镜导管（参考编号 7240）K193071Bashir Plus 内血管导管 K192598Bashir S-B 内血管导管，参考编号7101 K183290Bashir 内血管导管模型7201，Bashir N-X 内血管导管，型号7200

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。