PULSE*SPRAY INFUSION SYSTEM
Device Facts
| Record ID | K951509 |
|---|---|
| Device Name | PULSE*SPRAY INFUSION SYSTEM |
| Applicant | Angiodynamics, Div. E-Z-Em, Inc. |
| Product Code | QEY · Cardiovascular |
| Decision Date | Jun 16, 1995 |
| 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.
