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

CATHETER SYSTEM, COPE/EISENBERG

K Number: K772175 · Decision Nov 28, 1977
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
2
Review Days
7

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Basic Information

Device Name
CATHETER SYSTEM, COPE/EISENBERG
K Number
K772175
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Victory Engineering Corp.
Date Received
November 21, 1977
Decision Date
November 28, 1977
Product Code
DQO
Advisory Committee
Cardiovascular
Review Advisory Committee
RA
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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K Number Device Name
K771306 THERMOCATH