FDA 510(k)

INSPiRE SVR 1200, INSPiRE 6F C, INSPiRE 8F C

K 號：K161733 · 2017-03-08

決定日期2017-03-08

產品代碼DTN

諮詢委員會履歷

決定相當於

器材摘要

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K161733. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K161733.

When did INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C receive FDA 510(k) clearance?

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C received FDA 510(k) clearance on 2017-03-08, under 510(k) number K161733.

Who is the listed applicant for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C?

The FDA product code for INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C is DTN.

其他以 Sorin Group Italia S.R.L. 為申請人之記錄

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相關器械（代碼：DTN）

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。

K251783啟動HCR及HCR DUAL心臟切開儲存器Sorin Group Italia S.R.L.K241206量子灌流混合系統Spectrum Medical S.R.L.K241053MVR™ 靜脈蓄血袋800毫升；MVR™ 静脈蓄血袋1600毫升；MVR™ 靜脈蓄血袋配Cortiva™ 生物活性表面800毫升；MVR™ 静脈蓄血袋配Cortiva™ 生物活性表面1600毫升Medtronic Cardiac Surgery K223361BMR 1900 體育器材規範文本Sorin Group Italia S.R.L.K170583Intersept過濾式心內切術容器，配Cortiva生物活性表面Medtronic, Inc.

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