510(k) DEN170004
DEN170004 is an FDA 510(k) premarket notification submitted by Avenu Medical, Inc. for the device "Ellipsys Vascular Access System". The FDA issued a decision of De Novo Granted on June 22, 2018. The device falls under product code PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access), a Class II device regulated under 21 CFR 870.1252. Avenu Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 22, 2018
- Date Received
- January 10, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
- Device Class
- Class II
- Regulation Number
- 870.1252
- Review Panel
- CV
- Submission Type
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.