21 CFR 870.1210 — Catheter, Continuous Flush
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1210
Identification
A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRA | Catheter, Continuous Flush | 2 | 173 | 3rd Party |
| NPG | Catheter, Infusion, Syringe | 2 | 1 |