SHILEY PREBYPASS FILTER
Device Facts
| Record ID | K840450 |
|---|---|
| Device Name | SHILEY PREBYPASS FILTER |
| Applicant | Shiley, Inc. |
| Product Code | KRJ · Cardiovascular |
| Decision Date | Apr 17, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4280 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
