WavelinQ Plus EndoAVF System
FDA 510(k) clearance K192239 · decided 2019-10-17
Clearance details
- K-number
- K192239
- Device name
- WavelinQ Plus EndoAVF System
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-19
- Decision date
- 2019-10-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- PQK
- Device class
- 2
- Regulation number
- 870.1252
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| 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
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. recall (Z-2085-2014) | GE Healthcare, LLC | 2014-07-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |