← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K955304 # CRICKET (K955304) _Microvena Corp. · DQX · May 16, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955304 ## Device Facts - **Applicant:** Microvena Corp. - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** May 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires. ## Device Story CRICKET™ Multipurpose Steering Device and Tip Shaper; manual tool for interventional cardiology/radiology. Device features steering mechanism for guidewires and integrated shaping bar for distal tip modification. Used by clinicians to prepare guidewires prior to insertion. Benefits include improved guidewire maneuverability and customized tip geometry for navigation through vasculature. ## Clinical Evidence Bench testing only. Functional testing performed using MICROVENA guidewires; results confirmed successful shaping and maintenance of visual, functional, and tensile strength integrity. ## Technological Characteristics Manual handheld device; dual-function design (steering mechanism and shaping bar). No energy source, software, or electronic components. ## 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 Wire Shaper ([K862567](/device/K862567.md)) - MICROVENA Microtorquer pin vise ([K922060](/device/K922060.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} MICROVENA CORPORATION K955304 # 510(k) SUMMARY MAY 16 1996 Contact/Submitter: Jodi Locher, Manager, Regulatory Affairs Date Prepared: November 10, 1995 Trade Name: CRICKET™ Multipurpose Steering Device and Tip Shaper Common Name: Steering Device and Guide Wire Shaping Device Classification Name: Steering Device and Wire Shaper Predicate Devices: ACS Wire Shaper (K862567) MICROVENA Microtorquer pin vise (K922060) Device Description: The CRICKET™ is intended to be used as a steering mechanism Intended Use for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires. (revised February 13, 1996) Comparative Analysis: The CRICKET™ has the same intended use as the ACS Wire Shaper and the MICROVENA Microtorquer pin vise. Functional/Safety Testing: All current MICROVENA guidewires were successfully shaped with the CRICKET™ and the guidewires successfully passed visual, functional and tensile strength tests. (revised February 13, 1996) Conclusion: The CRICKET™ is substantially equivalent to the predicate devices based on intended use and the results of functional testing. 1861 Buerkle Road ▲ White Bear Lake, Minnesota 55110-5246 612-777-6700 ▲ Fax 612-777-4962 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955304](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955304) **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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