KST · System, Blood Collection, Vacuum-Assisted, Manual
Hematology · 21 CFR 864.9125 · Class 1
Overview
| Product Code | KST |
|---|---|
| Device Name | System, Blood Collection, Vacuum-Assisted, Manual |
| Regulation | 21 CFR 864.9125 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
Classification Rationale
Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
