ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
Device Facts
| Record ID | K002627 |
|---|---|
| Device Name | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER |
| Applicant | Atrium Medical Corp. |
| Product Code | DXE · Cardiovascular |
| Decision Date | Apr 26, 2001 |
| 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.
