Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → PDU — Catheter For Crossing Total Occlusions # PDU · Catheter For Crossing Total Occlusions _Cardiovascular · 21 CFR 870.1250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU ## Overview - **Product Code:** PDU - **Device Name:** Catheter For Crossing Total Occlusions - **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 57) Showing 20 most recent of 57 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252315](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K252315.md) | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | Sep 22, 2025 | SESE | | [K251158](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K251158.md) | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | Sep 11, 2025 | SESK | | [K251376](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K251376.md) | LimFlow ARC | LimFlow, Inc. | May 31, 2025 | SESE | | [K232562](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K232562.md) | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | Feb 28, 2024 | SESK | | [K230159](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K230159.md) | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | Aug 28, 2023 | SESE | | [K230594](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K230594.md) | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | Apr 25, 2023 | SESE | | [K221163](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K221163.md) | Tunnel Crossing Catheter | Tractus Vascular, LLC | Jan 19, 2023 | SESE | | [K221541](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K221541.md) | LimFlow ARC | LimFlow, Inc. | Aug 31, 2022 | SESE | | [K220544](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K220544.md) | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | Jun 29, 2022 | SESE | | [K211802](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K211802.md) | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | Mar 1, 2022 | SESE | | [K212468](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K212468.md) | Tigereye CTO-Crossing Catheter | Avinger, Inc. | Jan 6, 2022 | SESE | | [K203363](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K203363.md) | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | Aug 12, 2021 | SESE | | [K210664](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K210664.md) | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) | Ra Medical Systems,Inc | Jul 27, 2021 | SESE | | [K210839](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K210839.md) | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | Apr 20, 2021 | SESE | | [K201330](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K201330.md) | Tigereye CTO-Crossing Catheter | Avinger, Inc. | Sep 10, 2020 | SESE | | [K192211](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K192211.md) | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | Jan 17, 2020 | SESE | | [K183357](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K183357.md) | XableCath Crossing Catheter | Xablecath, Inc. | Jan 21, 2019 | SESE | | [K170349](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K170349.md) | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | May 24, 2017 | SESE | | [K162418](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K162418.md) | Pioneer Plus Catheter | Philips Volcano | Dec 2, 2016 | SESE | | [K161208](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU/K161208.md) | CROSSER CTO Recanalization Catheter | Bard Peripheral Vacular, Inc. | May 24, 2016 | SESE | ## Top Applicants - Avinger, Inc. — 10 clearances - Spectranetics Corp. — 7 clearances - Flowcardia, Inc. — 3 clearances - Lumend, Inc. — 3 clearances - Ra Medical Systems,Inc — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PDU) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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