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FDA 510(k)

CorMatrix Cor 补片 (3 cm x 5 cm)(单包装), CorMatrix Cor 补片 (4 cm x 7 cm)(单包装), CorMatrix Cor 补片 (7 cm x 10 cm)(单包装)

K号: K181038 · 2018-10-10

申请人Cormatrix Cardiovascular, Inc.
决定日期2018-10-10
产品代码PSQ
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

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is the device name listed in this FDA 510(k) record. The listed applicant is Cormatrix Cardiovascular, Inc.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K181038. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Cormatrix Cardiovascular, Inc.. The 510(k) number is K181038.

When did CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) receive FDA 510(k) clearance?

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) received FDA 510(k) clearance on 2018-10-10, under 510(k) number K181038.

Who is the listed applicant for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

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

What is the FDA product code for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

The FDA product code for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is PSQ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cormatrix Cardiovascular, 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。

K152127CorMatrix Tyke

相关器械（代码：PSQ）

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。

K221029PERI-GUARD 修复贴，补充 PERI-GUARD 修复贴Synovis Life Technologies, Inc.K221032Vascu-Guard 血管修复贴Synovis Life Technologies, Inc.K210331CardiaMend 心包和 epicardial 重建基质Helios Cardio, Inc.K200566ADAPT 组织Admedus Regen Pty, Ltd.K190882XenoSure 生物贴片Lemaitre VascularK191734MatriStem UBM 心包补片Acell, Inc.

官方来源

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