HIGH PRESSURE CONNECTING SETS, MODIFICATION
Device Facts
| Record ID | K914987 |
|---|---|
| Device Name | HIGH PRESSURE CONNECTING SETS, MODIFICATION |
| Applicant | E-Z-Em, Inc. |
| Product Code | DTL · Cardiovascular |
| Decision Date | May 20, 1992 |
| 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.
