Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K072419
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K072419
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 43016 US
Other 510(k) Applications for this Company
Contact
BARBARA LAW
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2007
Decision Date
11/09/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact