FDA 510(k)

Polaris X Unidirectional Steerable Diagnostic Catheter

K号: K233207 · 2023-10-27

决定日期2023-10-27

产品代码DRF

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

Polaris X™ Unidirectional Steerable Diagnostic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K233207. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Polaris X™ Unidirectional Steerable Diagnostic Catheter?

Polaris X™ Unidirectional Steerable Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Boston Scientific Corporation. The 510(k) number is K233207.

When did Polaris X™ Unidirectional Steerable Diagnostic Catheter receive FDA 510(k) clearance?

Polaris X™ Unidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2023-10-27, under 510(k) number K233207.

Who is the listed applicant for Polaris X™ Unidirectional Steerable Diagnostic Catheter?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Polaris X™ Unidirectional Steerable Diagnostic Catheter?

The FDA product code for Polaris X™ Unidirectional Steerable Diagnostic Catheter is DRF.

列明Boston Scientific Corporation为申报人的其他记录

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