CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
Device Facts
| Record ID | K863917 |
|---|---|
| Device Name | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. |
| Applicant | Cardio-Vascular Innovations, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Jan 6, 1987 |
| 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.