Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K183615
Device Classification Name
More FDA Info for this Device
510(K) Number
K183615
Device Name
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Applicant
Avenu Medical, Inc.
27123 Calle Arroyo, Suite 2101
San Juan Capistrano, CA 92675 US
Other 510(k) Applications for this Company
Contact
Dave Campbell
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2018
Decision Date
01/25/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact