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

STOCKERT CORONARY PERFUSION CANNULAE

K Number: K022280 · Decision Oct 11, 2002
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
9
Review Days
88

Basic Information

Device Name
STOCKERT CORONARY PERFUSION CANNULAE
K Number
K022280
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
870.4210
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
STOCKERT INSTRUMENTE GMBH
Date Received
July 15, 2002
Decision Date
October 11, 2002
Product Code
DWF
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
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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K Number Device Name
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K041558 STOCKERTIR PURGE CONTROL (APC) SYSTEM
K032213 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
K023622 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
K022321 STOCKERT V172-28 VENOUS FEMORAL CANNULA
K020571 STOCKERT CENTRIFUGAL PUMP CONSOLE
K011838 CENTRIFUGAL PUMP
K011088 SIII ALARM AMPLIFIER