FDA 510(k)

DABRA准分子激光系统（DABRA激光型号RA-308和DABRA导管型号2.0）

K号: K220544 · 2022-06-29

决定日期2022-06-29

产品代码PDU

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

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K220544. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K220544.

When did DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) receive FDA 510(k) clearance?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K220544.

Who is the listed applicant for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

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

What is the FDA product code for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

The FDA product code for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is PDU.

列明Ra 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。

K210664DABRA激光系统（DABRA激光型号RA-308和DABRA导管型号101）K170349RA-308 激光系统，准分子激光导管

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