510(k) K183615
K183615 is an FDA 510(k) premarket notification submitted by Avenu Medical, Inc. for the device "Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle". The FDA issued a decision of Substantially Equivalent on January 25, 2019. 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
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2019
- Date Received
- December 26, 2018
- Clearance Type
- Special
- 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.