Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K032008
Device Classification Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
More FDA Info for this Device
510(K) Number
K032008
Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
Other 510(k) Applications for this Company
Contact
JODI LYNN GREENIZEN
Other 510(k) Applications for this Contact
Regulation Number
880.5965
More FDA Info for this Regulation Number
Classification Product Code
LJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2003
Decision Date
07/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact