FDA 510(k)

NorthStar Mapping System (MAP01 或 MAP01-01)

K号: K261119 · 2026-06-30

决定日期2026-06-30

产品代码DQK

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

NorthStar Mapping System (MAP01 or MAP01-01) is the device name listed in this FDA 510(k) record. The listed applicant is Imricor Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K261119. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NorthStar Mapping System (MAP01 or MAP01-01)?

NorthStar Mapping System (MAP01 or MAP01-01) is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Imricor Medical Systems, Inc.. The 510(k) number is K261119.

When did NorthStar Mapping System (MAP01 or MAP01-01) receive FDA 510(k) clearance?

NorthStar Mapping System (MAP01 or MAP01-01) received FDA 510(k) clearance on 2026-06-30, under 510(k) number K261119.

Who is the listed applicant for NorthStar Mapping System (MAP01 or MAP01-01)?

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

What is the FDA product code for NorthStar Mapping System (MAP01 or MAP01-01)?

The FDA product code for NorthStar Mapping System (MAP01 or MAP01-01) is DQK.

列明Imricor Medical Systems, Inc.为申报人的其他记录

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