510(k) K090576

FOOTPRINT URINARY DRAINAGE CATHETER by Footprint Medical — Product Code EZD

K090576 is an FDA 510(k) premarket notification submitted by Footprint Medical for the device "FOOTPRINT URINARY DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on August 12, 2009. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Footprint Medical has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2009
Date Received
March 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type