Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K072705
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K072705
Device Name
Wire, Guide, Catheter
Applicant
ASAHI INTECC CO., LTD.
2500 RED HILL AVE, SUITE 210
SANTA ANA, CA 92705 US
Other 510(k) Applications for this Company
Contact
YOSHI TERAI
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
09/24/2007
Decision Date
10/23/2007
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