FEW · Class II · 21 CFR 876.5090

FDA Product Code FEW: Catheter, Malecot

Leading manufacturers include C.R. Bard, Inc., Cook Incorporated and Olympic Medical Corp..

6
Total
6
Cleared
132d
Avg days
1992
Since

FDA 510(k) Cleared Catheter, Malecot Devices (Product Code FEW)

6 devices
1–6 of 6
Cleared Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
K140085
Cook Incorporated
Gastroenterology & Urology · 309d
Cleared Apr 24, 2007
BARD MALECOT AND PEZZER DRAINS
K070879
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 22, 1998
MANAN MALECOT BASKET DRAINAGE CATHETER
K981258
Medical Device Technologies, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 26, 1996
MANAN MALECOT BASKET DRAINAGE CATHETER
K954147
Manan Medical Products, Inc.
Gastroenterology & Urology · 203d
Cleared Jun 11, 1992
OLYMPIC SMART SCALE CARE CENTER
K920423
Olympic Medical Corp.
Gastroenterology & Urology · 132d

About Product Code FEW - Regulatory Context