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

MEDI-DYNE ANGIOGRAPHIC CATHETER

K Number: K930694 · Decision Aug 2, 1993
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
4
Review Days
173

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Basic Information

Device Name
MEDI-DYNE ANGIOGRAPHIC CATHETER
K Number
K930694
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Medi-Dyne, Inc.
Date Received
February 10, 1993
Decision Date
August 2, 1993
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

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.

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Other Clearances by Medi-Dyne, Inc.

K Number Device Name
K000825 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
K970401 MEDI-DYNE GUIDING CATHETER
K931833 MODIFIED LUER