Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
FDA 510(k) clearance K183615 · decided 2019-01-25
Clearance details
- K-number
- K183615
- Device name
- Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
- Applicant
- Avenu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-01-25
- Days to decision
- 30 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Avenu Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) | Avenu Medical, Inc. | 2018-10-05 |
| Ellipsys Vascular Access System (DEN170004) | Avenu Medical, Inc. | 2018-06-22 |
| everlinQ endoAVF System (DEN160006) | Tva Medical, Inc. | 2018-06-22 |
Recalls involving this device
No recalls on record reference this clearance.