ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
Device Facts
| Record ID | K000004 |
|---|---|
| Device Name | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 |
| Applicant | Daig Corp. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Nov 29, 2000 |
| 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.