510(k) K093252

FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER by Footprint Medical, Inc. — Product Code LJS

K093252 is an FDA 510(k) premarket notification submitted by Footprint Medical, Inc. for the device "FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER". The FDA issued a decision of Substantially Equivalent on December 17, 2009. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Footprint Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2009
Date Received
October 16, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type