ROTABLATOR ROTATIONAL ANGIOPLASTY
Device Facts
| Record ID | K953997 |
|---|---|
| Device Name | ROTABLATOR ROTATIONAL ANGIOPLASTY |
| Applicant | Heart Technology Mfg., Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Dec 22, 1995 |
| 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.)
