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FDA 510(k)

PERI-STRIPS 干性 staples 线加固，带有 VERITAS 胶原基质和 SECURE GRIP 技术

K号: K213125 · 2021-10-27

申请人Synovis Life Technologies. Inc. (A Subsidiary of Baxter
决定日期2021-10-27
产品代码FTM
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies. Inc. (A Subsidiary of Baxter. It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K213125. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Synovis Life Technologies. Inc. (A Subsidiary of Baxter. The 510(k) number is K213125.

When did PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology receive FDA 510(k) clearance?

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology received FDA 510(k) clearance on 2021-10-27, under 510(k) number K213125.

Who is the listed applicant for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

The FDA 510(k) record lists Synovis Life Technologies. Inc. (A Subsidiary of Baxter as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology?

The FDA product code for PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is FTM.

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

相关器械（代码：FTM）

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。

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