← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K970494 # HANNIBAL GUIDEWIRE (K970494) _Schneider (Europe) GmbH · DQX · May 9, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K970494 ## Device Facts - **Applicant:** Schneider (Europe) GmbH - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** May 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. Schneider steerable stent support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device. Any use other than that intended is not recommended. ## Device Story HANNIBAL™ Guidewire; 0.014" diameter; 185-315 cm length. Stainless steel construction; PTFE-coated proximal shaft; radiopaque tungsten spring coil distal tip. Used by physicians in interventional cardiology to navigate coronary vasculature; reach/cross stenotic lesions; provide support for balloon catheters or stent delivery systems. Manual operation; provides tactile feedback to clinician for vessel navigation. Benefits include improved lesion access and device delivery during percutaneous coronary intervention. ## Clinical Evidence Bench testing only. Testing included bond strength, tip flexibility, coating adhesion, torque, and compatibility with interventional devices. Biocompatibility testing included hemolysis and cytotoxicity assays. ## Technological Characteristics 0.014" diameter guidewire; 185-315 cm length. Materials: stainless steel, PTFE coating, radiopaque tungsten spring coil. Distal tip is flexible and shapeable. Manual operation; no energy source. Sterilization and packaging consistent with predicate C-Thru guidewire. ## 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 - ACS Hi-Torque Extra S'port™ Guidewire - C-Thru Coronary Guidewire ## 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} 510(k) Summary for HANNIBAL™ Guidewire MAY - 9 1997 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is K970494 Date prepared: February 4, 1997 Sponsor: Schneider (Europe) AG Ackerstrasse 6 PO Box CH-6180 Bulach, Switzerland Contact: Rudolf Ott V.P. Clinical and Regulatory Affairs Phone: 011-411-8721179 Trade/Proprietary Name: HANNIBAL™ Guidewire Classification: Class II Equivalent Devices: ACS Hi-Torque Extra S'port™ Guidewire (performance) C-Thru Coronary Guidewire (materials, sterilization, packaging) Device Description The HANNIBAL™ Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil, which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The distal part of the coil is very flexible and shapeable. Intended Use - The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. - Schneider steerable stent support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device. - Any use other than that intended is not recommended. Technological characteristics Equivalence in technological characteristics was substantiated by comparative performance testing including bond strength, tip flexibility, coating adhesion, torque and compatibility with interventional devices. Because materials used were the same as those used in other Schneider guidewires, a reduced biocompatibility battery, consisting of hemolysis and cytotoxicity, was conducted. The results of all testing indicated that the HANNIBAL™ guidewire is equivalent to the ACS Hi-Torque Extra S'port™ guidewire and is, therefore, safe for the intended use. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K970494](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K970494) **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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