(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.
§ 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.