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510(k) Data Aggregation
K Number
K971615Device Name
PATTISON ESOPHAGEAL DILATOR
Manufacturer
Date Cleared
1997-07-24
(83 days)
Product Code
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.
Device Description
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K Number
K970890Device Name
#ES-32 SUCTION CATHETER 32 FR.
Manufacturer
Date Cleared
1997-05-23
(73 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tri-Med #ES-32 Suction Catheter is to be used to suction liquids and solids from the stomach and esophagus when deemed necessary by the physician.
Device Description
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K Number
K970982Device Name
T-RX RETRIEVAL FORCEPS
Manufacturer
Date Cleared
1997-05-09
(52 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TRI-MED SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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