510(k) K220683
- Device
- INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
- Applicant
- Penumbra, Inc.
- 510(k) number
- K220683
- Product code
- QEW
- Decision
- Unknown (SESU)
- Decision date
- 2022-10-04
- Date received
- 2022-03-08
- Regulation
- 870.5150
- Classification name
- Peripheral Mechanical Thrombectomy With Aspiration
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Sindokht (Sisi) Soltanzadeh
- Address
- One Penumbra Pl. Alameda CA US 94502 94502
FDA Registration Numbers
- 1048735
- 3002807314
- 3004593495
- 3004111573
- 2124215
- 1424778
- 3013944123
- 3010220595
- 3014687026
- 3030481118
- 3020347218
- 1061124
- 3004737415
- 3010047454
- 3040801290
- 1625425
- 3016704395
- 2030624
- 3008514120
- 3010041511
- 2183744
- 3013758550
- 2244478
- 1319211
- 3004198398
- 3005168196
- 3014498720
- 1064858
- 2032098
- 1644312
- 3015924373
- 2134265
- 2648729
- 3004859241
- 1000523114
- 3026567963
- 3020256033
- 3008700817
- 3006946276
- 3016591327
- 3010273872
- 3014590708
- 3014787927
- 3015615738
- 3027226463
- 2020394
- 3011642792
- 3010034260
- 1000121056
- 3011137372
- 3017823876
- 3011471056
- 3031823122
- 3001374820
- 3007695959
- 2011171
- 3009380063
- 2022435
- 9616684
- 1721676
- 1225687
- 3019807891
- 3025465918
- 1724474
- 9612164
- 3029444898
- 3031976597
- 3008439199
- 3034619061
- 3008114965
- 3005160949
- 3004832480
- 9681260
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code QEW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260599 | INDIGO® Aspiration System INDIGO Link | Penumbra, Inc. | 2026-04-24 |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. | 2026-02-05 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | 2026-02-05 |
| K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026-01-21 |
| K251207 | Sangria Thrombectomy System | Avantec Vascular Corporation | 2026-01-07 |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | 2025-12-18 |
| K251070 | Akura Thrombectomy System | Akura Medical | 2025-11-25 |
| K253323 | Protrieve Sheath | Inari Medical | 2025-10-29 |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | 2025-10-22 |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Penumbra, Inc. | 2025-10-16 |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-08-28 |
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025-06-13 |
| K251189 | Aventus Thrombectomy System | Inquis Medical | 2025-06-13 |
| K250787 | Liberant Thrombectomy System | Medtronic, Ireland | 2025-06-11 |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. | 2025-05-14 |