TFX MEDICAL GUIDEWIRE

K963320 · Tfx Medical Group · DQX · Dec 3, 1996 · Cardiovascular

Device Facts

• Record ID: K963320
• Device Name: TFX MEDICAL GUIDEWIRE
• Applicant: Tfx Medical Group
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

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 Story

Guidewire used to facilitate percutaneous catheter placement; directs catheter through blood vessels or natural channels. Device consists of stainless steel core wire, spring wire, optional ribbon wire, and optional PTFE coating. Available in fixed or moveable core designs; straight or 'J' tip configurations. Used by clinicians in clinical settings to navigate vasculature or body channels. Device provides mechanical support and guidance for catheter advancement. Benefits include improved trackability and navigation of catheters during interventional or diagnostic procedures. Excludes coronary and neurovascular applications.

Clinical Evidence

Bench testing only. Device performance verified against British Standard BS 7174: 1990: Part 4.

Technological Characteristics

Materials: Grade 302/304 stainless steel. Features: Fixed/moveable cores, optional ribbon wire, optional PTFE coating, straight or 'J' tips. Sterilization: Sterile finished products. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a guidewire to direct percutaneous catheters through blood vessels or natural channels. Contraindicated for use in coronary arteries and neurovasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Teleflex Guidewire (K850677/B)
• Teleflex Teflon® Coated Guidewire (K860258/A)
• Teleflex Steerable Guidewire (K871850)

Reference Devices

• 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, K935170, K935198, K941229)

Submission Summary (Full Text)

{0}

K963320
T
DEC -3 1996

# 510(k) SUMMARY

[As required by 21 CFR 807.92]

## 1. Submitter and Contact Person

Neil R. Armstrong
Group Regulatory Affairs Manager
TFX Medical Group
Tall Pines Park
Jaffrey NH 03452
Tel: [phone]
Fax: [phone]

## 2. Device Name

**Trade Name**
TFX Medical Guidewire

**Common Name**
Guidewire

**Classification Name**
Wire, Guide, Catheter
74 DQX; 21 CFR 870.1330; Class II medical device

## 3. Comparison Devices

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, K935170, K935198, K941229

Tall Pines Park
Jaffrey, NH 03452
[phone]
FAX [phone] or 6108

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4. Description of Device

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 key features of the TFX Medical Guidewire are:

☐ Core Wire
☐ Ribbon Wire (where fitted)
☐ Spring Wire
☐ 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

5. 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.