FDA 510(k)

PERI-GUARD修復貼片，SUPPLE PERI-GUARD修復貼片

K 號：K221029 · 2022-10-19

決定日期2022-10-19

產品代碼PSQ

諮詢委員會履歷

決定相當於

器材摘要

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K221029. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K221029.

When did PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch receive FDA 510(k) clearance?

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch received FDA 510(k) clearance on 2022-10-19, under 510(k) number K221029.

Who is the listed applicant for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

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

What is the FDA product code for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch?

The FDA product code for PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch is PSQ.

其他以 Synovis Life Technologies, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K223052Peri-Guard 及Supple Peri-Guard K221032Vascu-Guard 血管修復補貼

相關器械（代碼：PSQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221032Vascu-Guard 血管修復補貼Synovis Life Technologies, Inc.K210331CardiaMend 心包及心外膜重建維材Helios Cardio, Inc.K200566ADAPT 組織Admedus Regen Pty, Ltd.K190882XenoSure 生物貼片Lemaitre Vascular K191734MatriStem UBM 心包補片Acell, Inc.K183635PhotoFix 去細胞牛心包Cryolife, Inc.

官方來源

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