CATHETER, CARDIOVASCULAR, BALLOON TYPE
Device Facts
| Record ID | K883852 |
|---|---|
| Device Name | CATHETER, CARDIOVASCULAR, BALLOON TYPE |
| Applicant | Wb Intl., Inc. |
| Product Code | DXE · Cardiovascular |
| Decision Date | Dec 7, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
