510(k) K042126

PICC by Arrow Intl., Inc. — Product Code LJS

K042126 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "PICC". The FDA issued a decision of SESU on August 27, 2004. 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 Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
August 27, 2004
Date Received
August 6, 2004
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