510(k) K072391

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

K072391 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "PFM PICC". The FDA issued a decision of Substantially Equivalent on November 19, 2007. 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
November 19, 2007
Date Received
August 24, 2007
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