21 CFR 870.1200 — Catheter, Intravascular, Diagnostic
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1200
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 499 | 3rd Party |
| NLI | Catheter, Angiography, Reprocessed | 2 | 1 | |
| NUI | Ultrasound, Infusion, System | 2 | 4 | |
| OBI | Catheter, Pressure Monitoring, Cardiac | 2 | 1 | |
| OBJ | Catheter, Ultrasound, Intravascular | 2 | 78 | |
| OES | Cardiac Catheterization Kit | 2 | 0 | |
| OEZ | Cardiovascular Procedure Kit | 2 | 0 | |
| OFN | Winged Intravenous Catheterization Kit | 2 | 0 | |
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | 2 | 9 | |
| ORD | Optical Coherence Tomography, Intravascular Catheter | 2 | 0 | |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 2 | 30 |
