INDIGO® Aspiration System INDIGO Link
Device Facts
| Record ID | K260599 |
|---|---|
| Device Name | INDIGO® Aspiration System INDIGO Link |
| Applicant | Penumbra, Inc. |
| Product Code | QEW · Cardiovascular |
| Decision Date | Apr 24, 2026 |
| 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.
