Indigo Aspiration System - Modified 110 Aspiration Tubing
FDA 510(k) clearance K180939 · decided 2018-05-03
Clearance details
- K-number
- K180939
- Device name
- Indigo Aspiration System - Modified 110 Aspiration Tubing
- Applicant
- Penumbra, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-10
- Decision date
- 2018-05-03
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- QEW
- 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 |
|---|
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| RoVo Mechanical Thrombectomy System (K253730) | Verge Medical, Inc. | 2026-01-21 |
| Sangria™ Thrombectomy System (K251207) | Avantec Vascular Corporation | 2026-01-07 |
| Helo Thrombectomy System (K252956) | Endovascular Engineering, Inc. | 2025-12-18 |
| Akura Thrombectomy System (K251070) | Akura Medical | 2025-11-25 |
| Protrieve Sheath (K253323) | Inari Medical | 2025-10-29 |
| Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (K251185) | Intervene | 2025-10-22 |
| INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing (K252612) | Penumbra, Inc. | 2025-10-16 |
| Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057) | Imperative Care, Inc. | 2025-08-28 |
Recalls involving this device
No recalls on record reference this clearance.