510(k) K051672

POWERPICC by Bard Access Systems, Inc. — Product Code LJS

K051672 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "POWERPICC". The FDA issued a decision of Substantially Equivalent on November 23, 2005. 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. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2005
Date Received
June 23, 2005
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