Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K000598
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K000598
Device Name
Catheter, Percutaneous
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054-2807 US
Other 510(k) Applications for this Company
Contact
MARGARET ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2000
Decision Date
03/24/2000
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