510(k) K110914

TRIPLE LUMEN PFM PICC by Pfm Medical, Inc. — Product Code LJS

K110914 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "TRIPLE LUMEN PFM PICC". The FDA issued a decision of Substantially Equivalent on September 21, 2011. 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. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
April 1, 2011
Clearance Type
Traditional
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