Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280) → DRA — Catheter, Steerable # DRA · Catheter, Steerable _Cardiovascular · 21 CFR 870.1280 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA ## Overview - **Product Code:** DRA - **Device Name:** Catheter, Steerable - **Regulation:** [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 41) Showing 20 most recent of 41 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250529](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K250529.md) | Globe Introducer (601-01001) | Kardium, Inc. | Jun 3, 2025 | SESE | | [K233248](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K233248.md) | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | Dec 11, 2023 | SESE | | [K232321](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K232321.md) | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | Oct 31, 2023 | SESE | | [K223824](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K223824.md) | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor | Boston Scientific Corporation | Mar 22, 2023 | SESE | | [K221397](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K221397.md) | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | Sep 28, 2022 | SESE | | [K221044](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K221044.md) | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | May 5, 2022 | SESE | | [K211100](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K211100.md) | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | May 14, 2021 | SESE | | [K202620](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K202620.md) | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 13, 2020 | SESE | | [K192422](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K192422.md) | Steerable Introducer 12F | Freudenberg Medical, LLC | Oct 4, 2019 | SESE | | [K190167](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K190167.md) | MitraClip G4 Steerable Guide Catheter | Abbott | May 29, 2019 | SESE | | [K183174](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K183174.md) | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 26, 2018 | SESE | | [K172394](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K172394.md) | Steerable Guide Catheter | Abbott Vascular | Sep 6, 2017 | SESE | | [K162925](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K162925.md) | AcQGuide Steerable Sheath | Acutus Medical, Inc. | Apr 6, 2017 | SESE | | [K160919](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K160919.md) | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | Sep 20, 2016 | SESE | | [K161985](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K161985.md) | Steerable Guide Catheter | Abbott Vascular | Aug 7, 2016 | SESE | | [K152310](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K152310.md) | HeartLight Deflectable Sheath | Cardiofocus, Inc. | Feb 24, 2016 | SESE | | [K153304](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K153304.md) | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | Feb 1, 2016 | SESE | | [K151463](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K151463.md) | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | Aug 18, 2015 | SESE | | [K133552](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K133552.md) | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | Hansen Medical | Feb 7, 2014 | SESE | | [K123591](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA/K123591.md) | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | Dec 27, 2012 | SESE | ## Top Applicants - Catheter Research C/O Burditt, Bowles & Radzius — 4 clearances - Evalve, Inc. — 4 clearances - Medtronic Cryocath, LP — 4 clearances - Abbott Vascular — 3 clearances - Acutus Medical, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRA) **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:** Innolitics at https://innolitics.com