Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
The Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access is a single-use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who require hemodialysis, providing long-term vascular access. It is classified as FDA Class 2 under 21 CFR 870.1252 in the Cardiovascular specialty, requiring 510(k) premarket notification. The device enables minimally invasive creation of AV fistulae as an alternative to open surgery. Product code PQK; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQK
- Device Class
- FDA class 2
- Regulation Number
- 870.1252
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192239 | WavelinQ Plus EndoAVF System | Oct 17, 2019 | Substantially Equivalent | C.R. Bard, Inc. |
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | Aug 09, 2019 | Substantially Equivalent | Avenu Medical |
| K182796 | WavelinQ 4F EndoAVF System | Feb 06, 2019 | Substantially Equivalent | C.R. Bard, Inc. |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | Jan 25, 2019 | Substantially Equivalent | Avenu Medical, Inc. |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | Oct 05, 2018 | Substantially Equivalent | Avenu Medical, Inc. |
| DEN170004 | Ellipsys Vascular Access System | Jun 22, 2018 | Unknown | Avenu Medical, Inc. |
| DEN160006 | everlinQ endoAVF System | Jun 22, 2018 | Unknown | Tva Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.