Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070816
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K070816
Device Name
Introducer, Catheter
Applicant
MICRUS DESIGN TECHNOLOGY, INC.
9344 N.W. 13TH ST.
MIAMI, FL 33172 US
Other 510(k) Applications for this Company
Contact
MARIANNE GRUNWALDT, MS, CQE
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2007
Decision Date
09/19/2007
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