Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1380](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1380) → DRB — Stylet, Catheter # DRB · Stylet, Catheter _Cardiovascular · 21 CFR 870.1380 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB ## Overview - **Product Code:** DRB - **Device Name:** Stylet, Catheter - **Regulation:** [21 CFR 870.1380](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1380) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A catheter stylet is a wire that is run through a catheter or cannula to render it stiff. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220280](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K220280.md) | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | Aug 30, 2022 | SESE | | [K191469](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K191469.md) | Biotronik Stylets | Biotronik, Inc. | Aug 1, 2019 | SESE | | [K182660](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K182660.md) | GaltTWS | Galt Medical Corp. | May 30, 2019 | SESE | | [K170298](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K170298.md) | Liberator Beacon Tip Locking Stylet | Cook Incorporated | Oct 18, 2017 | SESE | | [K142116](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K142116.md) | LLD EZ | Spectranetics, Inc. | Aug 12, 2014 | SESE | | [K090163](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K090163.md) | STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 | St Jude Medical | Apr 1, 2009 | SESE | | [K080924](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K080924.md) | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | Apr 30, 2008 | SESE | | [K072864](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K072864.md) | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM | St. Jude Medical, Cardiac Rhythm Management Divisi | Mar 13, 2008 | SESE | | [K053019](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K053019.md) | ACUITY STEERABLE STYLET ACCESSORY | Guidant Corporation | Mar 3, 2006 | SESE | | [K052965](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K052965.md) | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Guidant Corporation | Feb 13, 2006 | SESE | | [K043401](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K043401.md) | SPECTRANETICS LLD CS, MODEL 518-039 | Spectranetics Corp. | Mar 16, 2005 | SESE | | [K040001](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K040001.md) | STEERABLE STYLET | Synovis Surgical Innovations | Mar 9, 2004 | SESE | | [K010906](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K010906.md) | MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 | Medtronic Vascular | Apr 5, 2001 | SESE | | [K003535](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K003535.md) | STYLET KIT, MODELS 6254,6282,6293 | Medtronic Vascular | Feb 8, 2001 | SESE | | [K002534](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K002534.md) | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 | Eupalamus, LLC | Oct 18, 2000 | SESE | | [K000955](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K000955.md) | PLACER MODEL 6232 STEERABLE STYLET | Medtronic Vascular | Jun 16, 2000 | SESE | | [K000366](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K000366.md) | FIXATION STYLETS, MODELS 335-287 AND 335-288 | Accufix Research Institute | Apr 14, 2000 | SESE | | [K992664](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K992664.md) | TFX MEDICAL STYLET CATHETER | Tfx Medical Group | Apr 13, 2000 | SESE | | [K993376](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K993376.md) | ENSTYLET MODELS EC0010, EC0020 | Endocardial Solutions, Inc. | Jan 5, 2000 | SESE | | [K992863](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K992863.md) | LEAD STYLET,MODELS 6505,6506,6507,6508 | Guidant Corp. | Nov 12, 1999 | SESE | ## Top Applicants - Medtronic Vascular — 3 clearances - Cardiac Pacemakers, Inc. — 2 clearances - Guidant Corporation — 2 clearances - Spectranetics Corp. — 2 clearances - St. Jude Medical, Cardiac Rhythm Management Divisi — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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