510(k) K073451

PRESSURE INJECTABLE PICC by Arrow International, Inc. — Product Code LJS

K073451 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "PRESSURE INJECTABLE PICC". The FDA issued a decision of Substantially Equivalent on January 15, 2008. 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. Arrow International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2008
Date Received
December 10, 2007
Clearance Type
Special
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