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

DIAGNOSTIC INTRAVASCULAR CATHETER

K Number: K923699 · Decision Dec 21, 1992
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
2
Review Days
150

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Basic Information

Device Name
DIAGNOSTIC INTRAVASCULAR CATHETER
K Number
K923699
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Applied Vascular
Date Received
July 24, 1992
Decision Date
December 21, 1992
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 Applied Vascular

K Number Device Name
K910006 AVD INTIMAX (TM) BILIARY CATHETER