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

EXACTA & CONNECTA STOPCOCKS W/EXTENSION

K Number: K823120 · Decision Nov 8, 1982
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
6
Review Days
17

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Basic Information

Device Name
EXACTA & CONNECTA STOPCOCKS W/EXTENSION
K Number
K823120
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Pioneer Viggo, Inc.
Date Received
October 22, 1982
Decision Date
November 8, 1982
Product Code
FMG
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FMG Stopcock, I.V. Set

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Other Clearances by Pioneer Viggo, Inc.

K Number Device Name
K813454 I.V. FILTER-PREVENT
K812159 INTRAVASCULAR CATHETER
K811171 VASCULON II I.V. CATHETER
K801537 START IT WITH & WITHOUT I.V. CATH. UNIT
K791809 BLOOD TRANSFUSION MICROFILTER