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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

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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