Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4450](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4450) → MJN — Catheter, Intravascular Occluding, Temporary # MJN · Catheter, Intravascular Occluding, Temporary _Cardiovascular · 21 CFR 870.4450 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN ## Overview - **Product Code:** MJN - **Device Name:** Catheter, Intravascular Occluding, Temporary - **Regulation:** [21 CFR 870.4450](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4450) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 90) Showing 20 most recent of 90 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243795](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K243795.md) | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | Sep 5, 2025 | SESE | | [K251358](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K251358.md) | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | Jun 24, 2025 | SESE | | [K221294](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K221294.md) | preCARDIA Occlusion System | Abiomed, Inc. | Jun 30, 2023 | SESU | | [K214060](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K214060.md) | LANDMARK REBOA Catheter | Zien Medical Technologies, Inc. | Sep 19, 2022 | SESE | | [K211610](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K211610.md) | Fogarty Occlusion Catheter | Edwards Lifesciences, LLC | Feb 14, 2022 | SESE | | [K212324](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K212324.md) | RenovoCath | Renovorx, Inc. | Aug 23, 2021 | SESE | | [K210602](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K210602.md) | AortaSTAT Occlusion Device | Renalpro Medical, Inc. | Jul 9, 2021 | SESE | | [K210358](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K210358.md) | Neurescue device | Neurescue Aps | May 21, 2021 | SESE | | [K201652](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K201652.md) | COBRA-OS Kit | Front Line Medical Technologies, Inc. | Feb 22, 2021 | SESK | | [K203540](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K203540.md) | Bridge Occlusion Balloon | Spectranetics, Inc. | Dec 23, 2020 | SESE | | [K200459](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K200459.md) | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | Jun 3, 2020 | SESE | | [K192786](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K192786.md) | Gatekeeper Balloon Catheter | Arch Catheter, LLC | Apr 25, 2020 | SESE | | [K193440](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K193440.md) | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | Jan 9, 2020 | SESE | | [K191606](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K191606.md) | RenovoCath | Renovorx, Inc. | Aug 7, 2019 | SESE | | [K183045](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K183045.md) | Eclipse 2L | Balt USA, LLC | Apr 30, 2019 | SESE | | [K183679](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K183679.md) | Occlusion Balloon Catheter | Qxmedical, LLC | Apr 24, 2019 | SESE | | [K182916](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K182916.md) | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular | Nov 16, 2018 | SESE | | [K180904](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K180904.md) | Sniper Infusion Catheter with Balloon Occlusion | Embolx, Inc. | Jun 8, 2018 | SESE | | [K172567](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K172567.md) | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | Jan 31, 2018 | SESE | | [K172790](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K172790.md) | ER-REBOA Catheter | Prytime Medical Devices, Inc. | Nov 8, 2017 | SESE | ## Top Applicants - LeMaitre Vascular, Inc. — 8 clearances - Micro Therapeutics, Inc. — 7 clearances - Prytime Medical Devices, Inc. — 5 clearances - NuMED, Inc. — 5 clearances - Renovorx, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN) **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. 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