MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
Device Facts
| Record ID | K891121 |
|---|---|
| Device Name | MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM |
| Applicant | Boston Scientific Corp |
| Product Code | DYB · Cardiovascular |
| Decision Date | Dec 5, 1989 |
| 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.
