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High Pressure Syringe - Transfer Tube

by Shenzhen Maiwei Biotech Co., Ltd.

510(k) K253048

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253048↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253048 Date16 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXT
Models / Variants
Transfer Tube
Device Class
Class II
Regulation
21 CFR Part 870.1650
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Injector and Syringe, Angiographic, designed for high-pressure fluid transfer in cardiovascular procedures. It includes a high-pressure syringe, pressure connecting tube, quick fill tube, spike, and transfer tube to facilitate precise contrast media or medication delivery during angiographic imaging.

The device is intended for single-use in controlled clinical settings and is classified as FDA Class II under regulation 870.1650. It is supplied sterile and must be handled in accordance with aseptic techniques. The components are compatible with standard angiographic systems and are regulated under FDA 510(k) clearance (K253048) and MDR compliance. No MRI safety information is specified.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary use of this high-pressure syringe set in a clinical setting?

    This device is specifically designed for high-pressure fluid transfer during cardiovascular procedures, such as angiographic imaging. It facilitates precise delivery of contrast media or medications, ensuring accurate visualization and treatment in controlled clinical settings.

  • Is this device intended for single-use or repeated use, and how should it be handled?

    The device is intended for single-use only in clinical settings. Due to its sterile packaging, it must be handled using aseptic techniques to maintain sterility and prevent contamination before use.

  • What components does this high-pressure syringe set include, and how are they connected?

    The set includes a high-pressure syringe, pressure connecting tube, quick fill tube, spike, and transfer tube. These components work together to enable controlled, high-pressure fluid transfer during angiographic procedures, ensuring compatibility with standard angiographic systems.

  • Does this device require any special storage conditions, and is it pre-sterilized?

    Yes, the device is supplied sterile and must be stored according to manufacturer guidelines to preserve sterility. Since it is intended for single-use, it should be kept in its original packaging until ready for use in a controlled clinical environment.

  • What regulatory pathways does this device follow, and which advisory committee oversees its classification?

    This device is classified under FDA Class II (870.1650) and follows the 510(k) clearance pathway, with a decision code of *SESE* (Substantially Equivalent). It is regulated under the Cardiovascular (CV) advisory committee and complies with MDR (Medical Device Regulation) standards. The FDA clearance number is K253048.