Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340) → DYB — Introducer, Catheter # DYB · Introducer, Catheter _Cardiovascular · 21 CFR 870.1340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB ## Overview - **Product Code:** DYB - **Device Name:** Introducer, Catheter - **Regulation:** [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 700) Showing 20 most recent of 700 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254248](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K254248.md) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Apr 23, 2026 | SESE | | [K254279](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K254279.md) | Edwards eSheath+ introducer set | Edwards Lifesciences | Apr 17, 2026 | SESE | | [K260091](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260091.md) | Aventus Introducer Sheath | Inquis Medical | Apr 13, 2026 | SESE | | [K260839](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260839.md) | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | Apr 10, 2026 | SESE | | [K260942](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260942.md) | AuST Steerable Sheath | CenterPoint Systems, LLC | Apr 7, 2026 | SESE | | [K260459](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260459.md) | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | Apr 6, 2026 | SESE | | [K260626](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260626.md) | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | Mar 26, 2026 | SESE | | [K260163](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K260163.md) | AuST CSP Introducer | CenterPoint Systems, LLC | Feb 19, 2026 | SESE | | [K254236](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K254236.md) | Peel-Away Introducer Sheath | VascuTech Medical, LLC | Feb 9, 2026 | SESE | | [K253652](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K253652.md) | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | Jan 22, 2026 | SESE | | [K252508](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252508.md) | Intri26 Introducer Sheath | Inari Medical, Inc. | Dec 17, 2025 | SESE | | [K253741](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K253741.md) | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | Dec 15, 2025 | SESE | | [K252309](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252309.md) | PerQseal Introducers | Vivasure Medical Limited | Oct 23, 2025 | SESE | | [K251838](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K251838.md) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Oct 21, 2025 | SESE | | [K252766](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252766.md) | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | Oct 8, 2025 | SESE | | [K252441](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252441.md) | Primero Safe Access System | South53, LLC | Sep 29, 2025 | SESE | | [K252227](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252227.md) | Pounce(TM) Sheath | Surmodics,Inc. | Sep 24, 2025 | SESE | | [K252027](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252027.md) | Vertex(TM) Catheter | Jupiter Endovascular | Sep 12, 2025 | SESE | | [K252364](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K252364.md) | Edwards eSheath Optima introducer set | Edwards Lifesciences | Aug 29, 2025 | SESE | | [K251051](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K251051.md) | AuST Steerable Sheath | CenterPoint Systems, LLC | Apr 30, 2025 | SESE | ## Top Applicants - St Jude Medical — 21 clearances - Cordis Corp. — 19 clearances - Terumo Medical Corp. — 19 clearances - Daig Corp. — 18 clearances - Merit Medical Systems, Inc. — 18 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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