← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K963320 # TFX MEDICAL GUIDEWIRE (K963320) _Tfx Medical Group · DQX · Dec 3, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963320 ## Device Facts - **Applicant:** Tfx Medical Group - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** Dec 3, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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](/device/K850677.md)/B) - Teleflex Teflon® Coated Guidewire ([K860258](/device/K860258.md)/A) - Teleflex Steerable Guidewire ([K871850](/device/K871850.md)) ## Reference Devices - Arrow International Inc. ([K914531](/device/K914531.md), [K924607](/device/K924607.md), [K924438](/device/K924438.md)) - Argon Medical Corporation ([K841926](/device/K841926.md), [K871297](/device/K871297.md)) - Cook Incorporated ([K901899](/device/K901899.md), [K920824](/device/K920824.md), [K920891](/device/K920891.md)) - Guidewire Technologies ([K902152](/device/K902152.md)/3) - Lake Region Manufacturing ([K770977](/device/K770977.md), [K864058](/device/K864058.md), [K871882](/device/K871882.md), [K901224](/device/K901224.md), [K914138](/device/K914138.md), [K921200](/device/K921200.md), [K935170](/device/K935170.md), [K935198](/device/K935198.md), [K941229](/device/K941229.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: (603) 532 7706 Fax: (603) 532 8211 ## 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 (603) 532-7706 FAX (603) 532-8211 or 6108 {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963320](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963320) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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