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

DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-

K Number: K830025 · Decision Mar 31, 1983
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
1
Review Days
86

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Basic Information

Device Name
DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-
K Number
K830025
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Medrad/Technology For People
Date Received
January 4, 1983
Decision Date
March 31, 1983
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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