6F MACH 1, MODEL 34356-XXX
Device Facts
| Record ID | K010874 |
|---|---|
| Device Name | 6F MACH 1, MODEL 34356-XXX |
| Applicant | Boston Scientific Corp |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jun 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
