INDIGO Aspiration System
FDA 510(k) clearance K163618 · decided 2017-05-24
Clearance details
- K-number
- K163618
- Device name
- INDIGO Aspiration System
- Applicant
- Penumbra, Inc.
- Decision
- Unknown
- Date received
- 2016-12-22
- Decision date
- 2017-05-24
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QEX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NeVa PV Thrombectomy Device (K253407) | Vesalio, Inc. | 2025-11-24 |
| MegaVac Mechanical Thrombectomy System (K171493) | Capture Vascular, Inc. | 2017-08-10 |
Recalls involving this device
No recalls on record reference this clearance.