K230668
- 510(k) number
- K230668
- Device name
- Disposable High-pressure Extension Lines
- Applicant
- Precision Medical Plastics , Ltd. CN
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2024-06-14
- Date received
- 2023-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K230668
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.