FDA 510(k)

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

K-Nummer: K253048 · 2026-04-16

AntragstellerShenzhen Maiwei Biotech Co., Ltd.

Entscheidungsdatum2026-04-16

ProduktcodeDXT

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653ACIST Pro Diagnosesystem (019304); Verarbeitungseinheit Bettmontage; AngioTouch Modul; ACIST Pro Wagen; Einzelsensorkabel; DreibandsensorkabelAcist Medical Systems, Inc.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.K244038High Pressure TubingShandong Int Medical Instruments Co., Ltd.

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