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

CIRIBART GYUDUBG CATGETER

K Number: K855103 · Decision Feb 18, 1986
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
8
Review Days
57

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Basic Information

Device Name
CIRIBART GYUDUBG CATGETER
K Number
K855103
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Mansfield Scientific, Inc.
Date Received
December 23, 1985
Decision Date
February 18, 1986
Product Code
DQO
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
DQO Catheter, Intravascular, Diagnostic

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Other Clearances by Mansfield Scientific, Inc.

K Number Device Name
K865017 ANGIOSCOPE
K870186 ENDOMYOCARDIAL BIOPSY DEVICE
K853850 EXPLORER
K852797 HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K851848 PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
K844752 TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
K841705 WEDGE PRESSURE CATHETER FLOW DIRECTED