510(k) K061661

STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 by Advanced Infusion, Inc. — Product Code MEB

K061661 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Advanced Infusion, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2006
Date Received
June 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type