21 CFR 870.1140 — Manometer, Blood-Pressure, Venous
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1140
Identification
A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRK | Manometer, Blood-Pressure, Venous | 2 | 9 | 3rd Party |
| OFE | Central Venous Blood Pressure Kit | 2 | 0 | |
| OFF | Central Venous Catheter Tray | 2 | 0 | |
| PFA | Non-Invasive Central Venous Manometer | 2 | 2 |
