FDA 510(k)

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

Numéro K : K231363 · 2023-09-27

DemandeurHantech Medical Device Co., Ltd.

Date de décision2023-09-27

Code produitNGT

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K231363. 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 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K231363.

When did Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) receive FDA 510(k) clearance?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) received FDA 510(k) clearance on 2023-09-27, under 510(k) number K231363.

Who is the listed applicant for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA 510(k) record lists Hantech Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is NGT.

Essais cliniques associés

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Dispositifs connexes (Code : NGT)

K250884Injection de chlorure de sodium 0,9 %, USP, seringue BD PosiFlush™ SPBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical 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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