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

SILASTIC INTRAVENOUS CATHETER UNIT

K Number: K790914 · Decision Jul 3, 1979
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
31
Review Days
50

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Basic Information

Device Name
SILASTIC INTRAVENOUS CATHETER UNIT
K Number
K790914
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5200
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Dow Corning Corp. Healthcare Industries Materials
Date Received
May 14, 1979
Decision Date
July 3, 1979
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

Similar 510(k) Clearances

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Other Clearances by Dow Corning Corp. Healthcare Industries Materials

K Number Device Name
K853186 SILASTIC INFLATABLE BONE PLUG H.P.
K844637 WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
K850255 DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
K843995 TF-II HIP PROSTHESIS
K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K840357 SSA HIP PROSTHESIS
K831479 METAL-BACKED ACETABULAR CUP
K812864 SILASTIC VOICE PROSTHESIS
K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K811679 SILASTIC TENDON PASSER H.P.
Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →