(102 days)
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.
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
I am sorry, but the provided text does not contain the detailed information required to fulfill your request. The document is a 510(k) summary for a medical guidewire and mentions "Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4." However, it does not provide the specific acceptance criteria, reported device performance in a table, details about the study (sample size, data provenance, ground truth, experts, adjudication, MRMC, or standalone performance), or information about the training set.
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Image /page/0/Picture/1 description: The image shows the logo for TFX Medical Incorporated. The logo is black and white and features the letters "TFX" in a bold, sans-serif font. The word "Medical" is written to the right of the letters "TFX", and the word "Incorporated" is written above the "cal" in "Medical". The logo is simple and modern, and it is likely used to represent the company's brand.
DEC - 3 1996
510(k) SUMMARY
[As required by 21 CFR 807.92]
Submitter and Contact Person 1.
Neil R. Armstrong Group Regulatory Affairs Manager TFX Medical Group Tall Pines Park Jaffrev NH 03452 Tel: (603) 532 7706 (603) 532 8211 Fax:
Device Name 2.
Trade Name TFX Medical Guidewire
Common Name Guidewire
Classification Name
Wire, Guide, Catheter 74 DQX; 21 CFR 870.1330; Class II medical device
Comparison Devices 3.
| Teleflex Guidewire - | K850677/B |
|---|---|
| Teleflex Teflon® Coated Guidewire - | K860258/A |
| Teleflex Steerable Guidewire - | K871850 |
Arrow International Inc. -K914531, K924607, K924438 Argon Medical Corporation -K841926, K871297 Cook Incorporated -K901899, K920824, K920891 Guidewire Technologies -K902152/3 Lake Region Manufacturing -K770977. K864058. K871882. K901224, K914138, K921200,
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
A. Definition of the Derivative
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Description of Device 4.
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
క్. 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.
6. Summary of Technological Characteristics
TFX Medical Guidewire will be made of stainless steel, with fixed or moveable cores, with or without a ribbon wire, with one or two straight or "J" form tips and will be available uncoated and p.t.f.e. coated. All these technical characteristics are the same as the predicate Teleflex Guidewires.
7. Summary of Performance Data
Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.