K192239 is an FDA 510(k) clearance for the WavelinQ Plus EndoAVF System. 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 C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on October 17, 2019, 59 days after receiving the submission on August 19, 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 | K192239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2019 |
| Decision Date | October 17, 2019 |
| Days to Decision | 59 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. |