Device Listing 1751495935

Listing Summary#

Listing key
1751495935
Premarket submission
K181725
Device
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Applicant
Avenu Medical, Inc.
Product code
PQK
Decision date
2018-10-05