INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
Device Facts
| Record ID | K923603 |
|---|---|
| Device Name | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION |
| Applicant | Kontron Instruments, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Mar 8, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.