PQK — Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access Class II
FDA product code PQK covers "Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access", a Class II medical device regulated under 21 CFR 870.1252. Submissions are reviewed by the Cardiovascular panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQK
- Device Class
- Class II
- Regulation Number
- 870.1252
- Submission Type
- 510(k)
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192239 | C.R. Bard | WavelinQ Plus EndoAVF System | Oct 17, 2019 |
| K191114 | Avenu Medical | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys… | Aug 9, 2019 |
| K182796 | C.R. Bard | WavelinQ 4F EndoAVF System | Feb 6, 2019 |
| K183615 | Avenu Medical | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys… | Jan 25, 2019 |
| K181725 | Avenu Medical | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No… | Oct 5, 2018 |
| DEN170004 | Avenu Medical | Ellipsys Vascular Access System | Jun 22, 2018 |
| DEN160006 | Tva Medical | everlinQ endoAVF System | Jun 22, 2018 |