Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K161887
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K161887
Device Name
Wire, Guide, Catheter
Applicant
Volcano Corporation
3721 Valley Centre Drive Suite 500
San Diego, CA 92130 US
Other 510(k) Applications for this Company
Contact
Brian Park
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2016
Decision Date
09/20/2016
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