CUSTOM CORONARY MANIFOLD KITS
Device Facts
| Record ID | K853749 |
|---|---|
| Device Name | CUSTOM CORONARY MANIFOLD KITS |
| Applicant | Procedure Products, Inc. |
| Product Code | DTL · Cardiovascular |
| Decision Date | Jan 13, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4290 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
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.
