Actuator, Syringe, Injector Type
The Injector-Type Syringe Actuator is a cardiovascular accessory device used to mechanically drive a syringe during contrast media or fluid injection procedures, ensuring controlled and reproducible delivery rates. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQF and it is regulated under 21 CFR 870.1670 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DQF
- Device Class
- FDA class 2
- Regulation Number
- 870.1670
- Medical Specialty
- Cardiovascular
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920177 | VERSA-VIAL | Jul 13, 1992 | Substantially Equivalent | Bioteque America, Inc. |
| K882723 | ALCON FLUID INJECTOR | Nov 08, 1988 | Substantially Equivalent | Alcon Laboratories |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | Mar 22, 1988 | Substantially Equivalent | Spectramed, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.