← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K802473 # BENZALKONIUM-HEPARIN COATED GUIDEWIRES (K802473) _Medrad, Inc. · DQX · Nov 12, 1980 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K802473 ## Device Facts - **Applicant:** Medrad, Inc. - **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md) - **Decision Date:** Nov 12, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1330 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K802473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K802473) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K802473