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FEW — Catheter, Malecot Class II

FDA Device Classification

Classification Details

Product Code
FEW
Device Class
Class II
Regulation Number
876.5090
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140085cook incorporatedUNIVERSA PERCULTANEOUS DRAINAGE CATHETERNovember 18, 2014
K070879c.r. bardBARD MALECOT AND PEZZER DRAINSApril 24, 2007
K981258medical device technologiesMANAN MALECOT BASKET DRAINAGE CATHETERApril 22, 1998
K954147manan medical productsMANAN MALECOT BASKET DRAINAGE CATHETERMarch 26, 1996
K954116technical productsSILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIPNovember 6, 1995
K920423olympic medicalOLYMPIC SMART SCALE CARE CENTERJune 11, 1992