FDA 510(k)

PIVO™

K 號：K193569 · 2020-01-21

決定日期2020-01-21

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

PIVO(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2020-01-21 under 510(k) number K193569. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PIVO(TM)?

PIVO(TM) is a medical device that received FDA 510(k) clearance on 2020-01-21. The listed applicant is Velano Vascular. The 510(k) number is K193569.

When did PIVO(TM) receive FDA 510(k) clearance?

PIVO(TM) received FDA 510(k) clearance on 2020-01-21, under 510(k) number K193569.

Who is the listed applicant for PIVO(TM)?

The FDA 510(k) record lists Velano Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIVO(TM)?

The FDA product code for PIVO(TM) is JKA.

其他以 Velano Vascular 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。

K201237維拉諾血管血液收集适配器 K200439維拉諾ExT擴展組 K190604PIVO K182897維拉諾血管 Q2 延長組 K163508PIVO K152924TIVA¿ (請注意，這裡的 "TIVA¿" 看起來像是一個未完成的標題或識別碼，因此無法進行翻譯。如果您能提供完整的句子或文本，我將能夠提供翻譯。)

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相關器械（代碼：JKA）

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。

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官方來源

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