FDA 510(k)

Injection de chlorure de sodium 0,9 %, USP, seringue BD PosiFlush™ SP

Numéro K : K250884 · 2025-12-02

Date de décision2025-12-02

Code produitNGT

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K250884. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250884.

When did 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe receive FDA 510(k) clearance?

0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe received FDA 510(k) clearance on 2025-12-02, under 510(k) number K250884.

Who is the listed applicant for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe?

The FDA product code for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is NGT.

Essais cliniques associés

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Dispositifs connexes (Code : NGT)

K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K231161Injection de chlorure de sodium 0,9 %, USP BD PosiFlush™ SF Saline Flush SeringueBecton, Dickinson and Company

Source officielle

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