ROTABLATOR, MODIFICATION
Device Facts
| Record ID | K933238 |
|---|---|
| Device Name | ROTABLATOR, MODIFICATION |
| Applicant | Heart Technology, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Aug 24, 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.)
