Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1330](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1330) → DQX — Wire, Guide, Catheter # DQX · Wire, Guide, Catheter _Cardiovascular · 21 CFR 870.1330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX ## Overview - **Product Code:** DQX - **Device Name:** Wire, Guide, Catheter - **Regulation:** [21 CFR 870.1330](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1330) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 763) Showing 20 most recent of 763 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260544](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K260544.md) | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | Mar 20, 2026 | SESE | | [K253746](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K253746.md) | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | Mar 19, 2026 | SESE | | [K253262](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K253262.md) | EmeryGlide™ (EG18008901) | Nano4imaging GmbH | Mar 6, 2026 | SESE | | [K253847](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K253847.md) | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | Jan 31, 2026 | SESE | | [K251385](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K251385.md) | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | Jan 21, 2026 | SESE | | [K252674](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K252674.md) | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | Jan 9, 2026 | SESE | | [K251596](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K251596.md) | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | Nov 9, 2025 | SESE | | [K250203](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K250203.md) | SureAx-Guide™ | Sureax Medical, LLC | Oct 17, 2025 | SESE | | [K250031](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K250031.md) | Amplatzer Guidewire | ABBOTT MEDICAL | Oct 3, 2025 | SESE | | [K251181](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K251181.md) | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | Merit Medical Ireland, Ltd. | Aug 29, 2025 | SESE | | [K250552](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K250552.md) | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | Jul 25, 2025 | SESE | | [K250075](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K250075.md) | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | Jun 13, 2025 | SESE | | [K243733](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K243733.md) | SION blue PLUS | Asahi Intecc Co., Ltd. | Apr 2, 2025 | SESE | | [K241962](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K241962.md) | Crossloop | Asahi Intecc Co., Ltd. | Mar 27, 2025 | SESE | | [K242597](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K242597.md) | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | Mar 5, 2025 | SESE | | [K241702](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K241702.md) | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | Feb 6, 2025 | SESE | | [K241521](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K241521.md) | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | Dec 10, 2024 | SESE | | [K242824](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K242824.md) | PTFE Guidewire | Lake Region Medical | Dec 6, 2024 | SESE | | [K240818](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K240818.md) | R2P Radifocus Glidewire Advantage | Terumo Corporation | Nov 26, 2024 | SESE | | [K240997](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K240997.md) | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | Nov 6, 2024 | SESE | ## Top Applicants - Asahi Intecc Co., Ltd. — 47 clearances - Advanced Cardiovascular Systems, Inc. — 45 clearances - Lake Region Mfg., Inc. — 31 clearances - Scimed Life Systems, Inc. — 30 clearances - Cordis Corp. — 25 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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