FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MEDCOMP'S FEMORAL VEIN CATHETERS

K Number: K860810 · Decision Apr 8, 1986
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
15
Applicant Total
46
Review Days
35

Basic Information

Device Name
MEDCOMP'S FEMORAL VEIN CATHETERS
K Number
K860810
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5540
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Applicant
MEDICAL COMPONENTS, INC.
Date Received
March 4, 1986
Decision Date
April 8, 1986
Product Code
LFK
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LFK Catheter, Femoral

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K011576 MEDCOMP ASH SPLIT
K003207 MEDCOMP ULTRA-FLOW CATHETER
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K003682 MEDCOMP Z-CATH
K991320 MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K980438 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
K983511 SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
K974236 MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
Search all 46 clearances from MEDICAL COMPONENTS, INC. →