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

PHYSIO-PROBE-HIGH PERMEABILITY CATH.

K Number: K833433 · Decision Dec 29, 1983
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
5
Review Days
85

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Basic Information

Device Name
PHYSIO-PROBE-HIGH PERMEABILITY CATH.
K Number
K833433
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1250
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Research Industries Corp.
Date Received
October 5, 1983
Decision Date
December 29, 1983
Product Code
DQY
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
DQY Catheter, Percutaneous

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K Number Device Name
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K832542 I.V. ADMINISTRATION SET
K831769 VARIOUS CARDIOVASCULAR SURGICAL DEVICE
K831759 INTRACARDIA SUCKERS