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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 a medical device manufactured by Shenzhen Maiwei Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under approval 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. It is manufactured by Shenzhen Maiwei Biotech Co., Ltd.. The 510(k) number is K253048.

When was High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube approved by the FDA?

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

What company makes 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 manufactured by Shenzhen Maiwei Biotech Co., Ltd..

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 Clinical Trials

NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT06779617 UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07557771 Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function. RECRUITING NCT07387276 "Recovery Techniques on Pain, Force and Muscle Oxygenation in Athletes: A Crossover Trial" NOT_YET_RECRUITING NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED

Related Devices (Code: DXT)

K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd. K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc. K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. K152978DeRoyal Angiography KitsDeroyal Industries, Inc.

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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