Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140796
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K140796
Device Name
Device, Vascular, For Promoting Embolization
Applicant
ENDOSHAPE, INC.
2450 Central Ave Ste I
Boulder, CO 80301 US
Other 510(k) Applications for this Company
Contact
MICHAEL PARMENTER
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2014
Decision Date
12/02/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact