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

DESERET SPLITTABLE CATHETER

K Number: K874582 · Decision Dec 29, 1987
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
20
Review Days
50

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Basic Information

Device Name
DESERET SPLITTABLE CATHETER
K Number
K874582
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5200
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Deseret Medical, Inc.
Date Received
November 9, 1987
Decision Date
December 29, 1987
Product Code
FOZ
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
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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Other Clearances by Deseret Medical, Inc.

K Number Device Name
K913027 VESSEL DILATOR
K904648 SAFE SYTE I.V. CATHETER PLACEMENT UNIT
K904121 VIALON OBTURATOR
K904122 INSYTE-A ARTERIAL CATHETERIZATION UNIT
K900116 DESERET OPTIMA INTRAVASCULAR CATHETER
K895735 DESERET MULTILUMEN SUBCLAVIAN CATHETER
K895734 DESERET INTRAVASCULAR CATHETER
K894033 DISPOSABLE CATHETER PRESSURE TRANSDUCER
K893406 DESERET PRN ADAPTER
K882797 LUER-LOK MULTIFLO ADAPTER
Search all 20 clearances from Deseret Medical, Inc. →