K191114 is an FDA 510(k) clearance for the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle. This device is classified as a Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access (Class II - Special Controls, product code PQK).
Submitted by Avenu Medical (San Juan Capistrano, US). The FDA issued a Cleared decision on August 9, 2019, 105 days after receiving the submission on April 26, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1252. 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) Number | K191114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2019 |
| Decision Date | August 09, 2019 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PQK - Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1252 |
| 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. |