Medrad Qwik-Fit Syringe
by Medrad, Inc.
510(k) K013815
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013815 | Date13 Dec 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1650
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 5 Oct 2026
The Medrad Qwik-Fit Syringe is a disposable angiographic syringe designed to assist in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes. The device consists of a clear plastic barrel and a plunger assembly, operating as a high-pressure syringe with compatible injector systems.
The device is a disposable, single-use component provided as part of angiographic injector systems. It has received regulatory clearance under FDA 510(k) number K013815 as a Class II angiographic injector and syringe.
Other devices from Medrad, Inc.
Questions
AI-generated answers, 5 Oct 2026
What is the Medrad Qwik-Fit Syringe used for?
It is a high-pressure disposable syringe used to assist in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes when used with compatible injector systems.
Can this syringe be reused?
No. The Medrad Qwik-Fit Syringe is designated as a disposable, single-use component.
What are the components of the syringe?
It is constructed from a clear plastic barrel paired with a plunger assembly.
What is the regulatory clearance for this device?
The device received FDA 510(k) clearance under premarket notification number K013815 as a Class II angiographic injector and syringe.