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

I.V. CATHETER

K Number: K772354 · Decision Jan 31, 1978
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
11
Review Days
35

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Basic Information

Device Name
I.V. CATHETER
K Number
K772354
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5200
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Ndm Corp.
Date Received
December 27, 1977
Decision Date
January 31, 1978
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 Ndm Corp.

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K853968 DIATEMP ELECTROSURGICAL PEN
K830663 PENCIL SKIN ABRADER
K810920 NDM DIATEMP INFANT ELECTROSURG. DISP. P.
K801158 NDM DIATEMP ELECTROSURGICAL DIS. PAD
K790730 NDM PAPER TAPE ECG ELECTRODE
K772160 ELECTROSURGICAL GROUNDING PAD
K761301 V-TRACE ECG BACKPAD
K760312 ELECTRODE, PNS
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