Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K110914
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
More FDA Info for this Device
510(K) Number
K110914
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
PFM MEDICAL, INC
1815 ASTON AVE
SUITE 106
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
SALVADORE PALOMARES
Other 510(k) Applications for this Contact
Regulation Number
880.5970
More FDA Info for this Regulation Number
Classification Product Code
LJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2011
Decision Date
09/21/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact