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Found 6 results
510(k) Data Aggregation
K Number
K022112Device Name
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
2003-04-03
(279 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stomach (Gastric) Tube is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
Device Description
All Silicone Stomach (Gastric) Tube (Model 2020)
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K Number
K021193Device Name
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
2003-02-12
(303 days)
Product Code
HDB
Regulation Number
884.4340Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.
Device Description
Not Found
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K Number
K021142Device Name
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
2002-10-01
(175 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To pass fluid to and from the urinary bladder after prostatectomy.
Device Description
Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.
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K Number
K014002Device Name
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
2002-03-04
(90 days)
Product Code
KOB
Regulation Number
876.5090Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.
Device Description
Not Found
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K Number
K980917Device Name
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
1998-05-27
(77 days)
Product Code
GCA, DAT
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.
Device Description
All Silicone T-Drainage Tube w/wo Eyes All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube
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K Number
K980919Device Name
ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
Manufacturer
FORTUNE MEDICAL INSTRUMENT CORP.
Date Cleared
1998-03-31
(20 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
FORTUNE MEDICAL INSTRUMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.
Device Description
All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter
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