Injector, Indicator
The Indicator Injector is a cardiovascular device used to introduce indicator substances (such as dye or contrast agents) into the circulatory system for diagnostic measurement purposes, typically in procedures assessing cardiac output or blood flow. It is classified as FDA Class 2, meaning it presents moderate risk and requires a 510(k) premarket notification before marketing. The product code is DXL and the applicable regulation is 21 CFR 870.1660, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DXL
- Device Class
- FDA class 2
- Regulation Number
- 870.1660
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- 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 |
|---|---|---|---|---|
| K760500 | TUBE, HEAVY GLASS WALL INJECTION | Sep 03, 1976 | Substantially Equivalent | Unimetrics Corp. |
| K760448 | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | Aug 27, 1976 | Substantially Equivalent | Instrumentation Laboratory CO |
| K760066 | TRAY, ICED INJECTABLE (26420) | Jul 21, 1976 | Substantially Equivalent | Instrumentation Laboratory CO |