Protaryx 隔膜穿刺器 (PTX2-001)
K 號：K260839 · 2026-04-10
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器材摘要
Protaryx Transseptal Puncture Device (PTX2-001) is the device name listed in this FDA 510(k) record. The listed applicant is Protaryx Medical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260839. 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 Protaryx Transseptal Puncture Device (PTX2-001)?
Protaryx Transseptal Puncture Device (PTX2-001) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Protaryx Medical, Inc.. The 510(k) number is K260839.
When did Protaryx Transseptal Puncture Device (PTX2-001) receive FDA 510(k) clearance?
Protaryx Transseptal Puncture Device (PTX2-001) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260839.
Who is the listed applicant for Protaryx Transseptal Puncture Device (PTX2-001)?
The FDA 510(k) record lists Protaryx Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Protaryx Transseptal Puncture Device (PTX2-001)?
The FDA product code for Protaryx Transseptal Puncture Device (PTX2-001) is DYB.
相關臨床試驗
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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。
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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。
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