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510(k) Data Aggregation
K Number
K992664Device Name
TFX MEDICAL STYLET CATHETER
Manufacturer
TFX MEDICAL GROUP
Date Cleared
2000-04-13
(248 days)
Product Code
DRB
Regulation Number
870.1380Why did this record match?
Applicant Name (Manufacturer) :
TFX MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.
Device Description
The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.
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K Number
K991647Device Name
TFX MEDICAL INTRODUCER KIT
Manufacturer
TFX MEDICAL GROUP
Date Cleared
2000-01-04
(236 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
TFX MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.
Device Description
The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray
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K Number
K963320Device Name
TFX MEDICAL GUIDEWIRE
Manufacturer
TFX MEDICAL GROUP
Date Cleared
1996-12-03
(102 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
TFX MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.
Device Description
TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).
The kev features of the TFX Medical Guidewire are:
- O Core Wire
- O Ribbon Wire (where fitted)
- O Spring Wire
- O Welds
- Coating (p.t.f.e. coating or uncoated stainless steel)
- Tips (available straight and "J" forms, one or two tips)
Guidewires will be manufactured of grade 302/304 stainless steel and be available:
- . with and without a ribbon wire
- ♥ in fixed and moveable core designs
- . uncoated and p.t.f.e. coated
- with straight and "J" formed end(s)
- with and without a length marking
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