CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
Device Facts
| Record ID | K872485 |
|---|---|
| Device Name | CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) |
| Applicant | Ideas For Medicine, Inc. |
| Product Code | DXE · Cardiovascular |
| Decision Date | Aug 12, 1987 |
| 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.
