510(k) K072481

JET PORT PLUS HP CATHETER SYSTEM by Pfm Medical, Inc. — Product Code LJT

K072481 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "JET PORT PLUS HP CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2008. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2008
Date Received
September 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type