Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K123111
Device Classification Name
More FDA Info for this Device
510(K) Number
K123111
Device Name
V8 TRANSLUMINAL BAV CATHETER
Applicant
INTERVALVE, INC
84801 73RD AVENUE NORTH,
SUITE 63
MINNEAPOLIS, MN 55428 US
Other 510(k) Applications for this Company
Contact
JULIE BODMER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2012
Decision Date
01/31/2013
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