Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071226
Device Classification Name
More FDA Info for this Device
510(K) Number
K071226
Device Name
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
Applicant
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS, CO 80907-5159 US
Other 510(k) Applications for this Company
Contact
MICHAEL K HANDLEY
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2007
Decision Date
06/29/2007
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