ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Device Facts
| Record ID | K924712 |
|---|---|
| Device Name | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |
| Applicant | Hearing Tech, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Dec 8, 1992 |
| 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.)
