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

MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER

K Number: K955839 · Decision Mar 25, 1996
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
11
Review Days
90

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Basic Information

Device Name
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
K Number
K955839
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5200
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Baxter Edwards
Date Received
December 26, 1995
Decision Date
March 25, 1996
Product Code
FOZ
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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K980487 CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
K965137 FOGARTY VALVULOTOME MODEL 700091
K964021 INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K952638 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
K944214 BAXTER HANDLE MODEL 1150
K944858 BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
K940795 SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
K926433 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45
Search all 11 clearances from Baxter Edwards →