Ellipsys Vascular Access System
FDA 510(k) clearance DEN170004 · decided 2018-06-22
Clearance details
- K-number
- DEN170004
- Device name
- Ellipsys Vascular Access System
- Applicant
- Avenu Medical, Inc.
- Decision
- Unknown
- Date received
- 2017-01-10
- Decision date
- 2018-06-22
- Days to decision
- 528 days
- Clearance type
- Direct
- Product code
- PQK
- Device class
- 2
- Regulation number
- 870.1252
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Juan Capistrano, 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 |
|---|---|---|
| WavelinQ Plus EndoAVF System (K192239) | C.R. Bard, Inc. | 2019-10-17 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (K191114) | Avenu Medical | 2019-08-09 |
| WavelinQ 4F EndoAVF System (K182796) | C.R. Bard, Inc. | 2019-02-06 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle (K183615) | Avenu Medical, Inc. | 2019-01-25 |
| Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) | Avenu Medical, Inc. | 2018-10-05 |
| everlinQ endoAVF System (DEN160006) | Tva Medical, Inc. | 2018-06-22 |
Recalls involving this device
No recalls on record reference this clearance.