510(k) K093026

FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER by Footprint Medical — Product Code DYB

K093026 is an FDA 510(k) premarket notification submitted by Footprint Medical for the device "FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER". The FDA issued a decision of Substantially Equivalent on February 24, 2010. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Footprint Medical has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2010
Date Received
September 29, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type