FDA 510(k)

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

Numéro K : K253048 · 2026-04-16

DemandeurShenzhen Maiwei Biotech Co., Ltd.

Date de décision2026-04-16

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253048. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Shenzhen Maiwei Biotech Co., Ltd.. The 510(k) number is K253048.

When did High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube receive FDA 510(k) clearance?

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253048.

Who is the listed applicant for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA 510(k) record lists Shenzhen Maiwei Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube?

The FDA product code for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube is DXT.

Essais cliniques associés

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Dispositifs connexes (Code : DXT)

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Source officielle

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