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FDA 510(k)

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

K-Number: K253048 · 2026-04-16

ApplicantShenzhen Maiwei Biotech Co., Ltd.
Decision Date2026-04-16
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: DXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.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.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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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