510(k) K130507

FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER by Footprint Medical, Inc. — Product Code LJS

K130507 is an FDA 510(k) premarket notification submitted by Footprint Medical, Inc. for the device "FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER". The FDA issued a decision of Substantially Equivalent on June 3, 2013. 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
June 3, 2013
Date Received
February 27, 2013
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