21 CFR 870.1370 — Occluder, Catheter Tip
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1370
Identification
A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQT | Occluder, Catheter Tip | 2 | 12 | 3rd Party |