High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube— 510(k) K253048
Substantially EquivalentShenzhen Maiwei Biotech Co., Ltd.
FDA 510(k) clearance K253048 for High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube, Substantially Equivalent on 2026-04-16. Applicant: Shenzhen Maiwei Biotech Co., Ltd.. Device class: 2.
Summary
Shenzhen Maiwei Biotech's record names five items: a High Pressure Syringe, Pressure Connecting Tube, Quick fill tube, Spike, and Transfer Tube. All are filed under product code DXT (Injector And Syringe, Angiographic).
Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Shenzhen Maiwei Biotech filed from Shenzhen, China. The record shows 206 calendar days from receipt to decision (September 22, 2025 to April 16, 2026).
Clearance details
- Applicant
- Shenzhen Maiwei Biotech Co., Ltd.
- Product code
- Product code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DXT
view all- K262043 — MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more
- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K251788 — Extension tube
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.