NLI · Catheter, Angiography, Reprocessed
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | NLI |
|---|---|
| Device Name | Catheter, Angiography, Reprocessed |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC | Jul 1, 2024 | SESE |
Top Applicants
- Innovative Health, LLC — 1 clearance
