510(k) K070879

BARD MALECOT AND PEZZER DRAINS by C.R. Bard, Inc. — Product Code FEW

K070879 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD MALECOT AND PEZZER DRAINS". The FDA issued a decision of Substantially Equivalent on April 24, 2007. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2007
Date Received
March 30, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type