KSD · Device, Heat-Sealing
Hematology · 21 CFR 864.9750 · Class 1
Overview
| Product Code | KSD |
|---|---|
| Device Name | Device, Heat-Sealing |
| Regulation | 21 CFR 864.9750 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | North American Biologicals, Inc. | Apr 9, 1982 | SESE |
Top Applicants
- North American Biologicals, Inc. — 1 clearance
