Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970470
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
More FDA Info for this Device
510(K) Number
K970470
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
GUIDANT CARDIAC AND VASCULAR SURGERY
1360 O'BRIEN DR.
MENLO PARK, CA 94025 US
Other 510(k) Applications for this Company
Contact
LUANNE TERMEER
Other 510(k) Applications for this Contact
Regulation Number
870.1310
More FDA Info for this Regulation Number
Classification Product Code
DRE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/07/1997
Decision Date
07/31/1997
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