DXL · Injector, Indicator
Cardiovascular · 21 CFR 870.1660 · Class 2
Overview
| Product Code | DXL |
|---|---|
| Device Name | Injector, Indicator |
| Regulation | 21 CFR 870.1660 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K760500 | TUBE, HEAVY GLASS WALL INJECTION | Unimetrics Corp. | Sep 3, 1976 | SESE |
| K760448 | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | Instrumentation Laboratory CO | Aug 27, 1976 | SESE |
| K760066 | TRAY, ICED INJECTABLE (26420) | Instrumentation Laboratory CO | Jul 21, 1976 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 2 clearances
- Unimetrics Corp. — 1 clearance
