510(k) K002471

JETCAN HUBER NEEEDLE SET by Pfm Produkte Fur Die Medizin AG — Product Code FPA

K002471 is an FDA 510(k) premarket notification submitted by Pfm Produkte Fur Die Medizin AG for the device "JETCAN HUBER NEEEDLE SET". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pfm Produkte Fur Die Medizin AG has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
August 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type