TSP Crosser 隔膜穿刺通路系統
K 號：K181088 · 2018-09-28
廣告
器材摘要
TSP Crosser Transseptal Access System is the device name listed in this FDA 510(k) record. The listed applicant is Transseptal Solutions , Ltd.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181088. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TSP Crosser Transseptal Access System?
TSP Crosser Transseptal Access System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Transseptal Solutions , Ltd.. The 510(k) number is K181088.
When did TSP Crosser Transseptal Access System receive FDA 510(k) clearance?
TSP Crosser Transseptal Access System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181088.
Who is the listed applicant for TSP Crosser Transseptal Access System?
The FDA 510(k) record lists Transseptal Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TSP Crosser Transseptal Access System?
The FDA product code for TSP Crosser Transseptal Access System is DYB.
相關臨床試驗
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。
相關器械（代碼：DYB）
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。
K253526NAMIC 扩張器及套管Medline Industries, LPK261529微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（SIS05C）；微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（IS01）；導入器套件 / 微導入器套件 / 導入器組 / 微導入器組 / 微導入器鞘組 / 導入器鞘組（NIS04）Hartman Medical Group, LLCK261242簡易導引PendracareK261950健康線拆離導入器Health Line International CorporationK261492FieldFlex 經導鞘CenterPoint Systems, LLCK260606回聲大內徑導入鞘Echo Medical, LLC
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告