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510(k) K253048

High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube by Shenzhen Maiwei Biotech Co., Ltd. — Product Code DXT

K253048 is an FDA 510(k) premarket notification submitted by Shenzhen Maiwei Biotech Co., Ltd. for the device "High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
September 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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  • K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-U (May 13, 2026)
  • K251788 — Extension tube (March 5, 2026)
  • K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD (February 13, 2026)
  • K244038 — High Pressure Tubing (September 5, 2025)
  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)

FDA data resources