INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
Device Facts
| Record ID | K922970 |
|---|---|
| Device Name | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM |
| Applicant | Intensive Technology, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Jan 13, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
