預言 IDeal 9F 水性鞘導管輔助器
K 號：K212152 · 2022-01-07
廣告
器材摘要
Prelude IDeal 9F Hydrophilic Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K212152. 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 Prelude IDeal 9F Hydrophilic Sheath Introducer?
Prelude IDeal 9F Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Merit Medical Systems. The 510(k) number is K212152.
When did Prelude IDeal 9F Hydrophilic Sheath Introducer receive FDA 510(k) clearance?
Prelude IDeal 9F Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2022-01-07, under 510(k) number K212152.
Who is the listed applicant for Prelude IDeal 9F Hydrophilic Sheath Introducer?
The FDA 510(k) record lists Merit Medical Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer?
The FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer 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