FDA 510(k)

BD Saf-T-Intima™ 皮下单腔導管系統

K 號：K251422 · 2025-10-08

申請人Becton Dickinson Infusion Therapy Systems, Inc.

決定日期2025-10-08

產品代碼FOZ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

BD Saf-T-Intima™ Subcutaneous Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K251422. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Saf-T-Intima™ Subcutaneous Catheter System?

BD Saf-T-Intima™ Subcutaneous Catheter System is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K251422.

When did BD Saf-T-Intima™ Subcutaneous Catheter System receive FDA 510(k) clearance?

BD Saf-T-Intima™ Subcutaneous Catheter System received FDA 510(k) clearance on 2025-10-08, under 510(k) number K251422.

Who is the listed applicant for BD Saf-T-Intima™ Subcutaneous Catheter System?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Saf-T-Intima™ Subcutaneous Catheter System?

The FDA product code for BD Saf-T-Intima™ Subcutaneous Catheter System is FOZ.