Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5050](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5050) → DWM — Apparatus, Suction, Patient Care # DWM · Apparatus, Suction, Patient Care _Cardiovascular · 21 CFR 870.5050 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM ## Overview - **Product Code:** DWM - **Device Name:** Apparatus, Suction, Patient Care - **Regulation:** [21 CFR 870.5050](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5050) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K212696](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K212696.md) | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | Mar 3, 2023 | SESE | | [K210509](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K210509.md) | Rocket Platinum Cured Cathter | Rocket Medical Plc | Sep 9, 2021 | SESK | | [K201404](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K201404.md) | Passio Pump Drainage System | Bearpac Medical | Nov 20, 2020 | SESE | | [K190292](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K190292.md) | Passio Pump Drainage System | Bearpac Medical | Jul 25, 2019 | SESE | | [K163321](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K163321.md) | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | Aug 17, 2017 | SESE | | [K160450](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K160450.md) | Pleurx Pleural Catheter System | Care Fusion | Oct 31, 2016 | SESE | | [K141965](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K141965.md) | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | Jul 2, 2015 | SESE | | [K123033](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K123033.md) | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Rocket Medical Plc | Feb 1, 2013 | SESE | | [K121849](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K121849.md) | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE | Care Fusion | Oct 18, 2012 | SESE | | [K112831](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K112831.md) | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | Feb 16, 2012 | SESE | | [K110409](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K110409.md) | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | May 11, 2011 | SESE | | [K093307](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K093307.md) | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | Nov 6, 2009 | SESE | | [K071095](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K071095.md) | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | May 18, 2007 | SESE | | [K052436](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K052436.md) | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | Oct 6, 2005 | SESE | | [K051084](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K051084.md) | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | Denver Biomedicals, Inc. | Jun 13, 2005 | SESE | | [K011831](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K011831.md) | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | Jun 28, 2001 | SESE | | [K010642](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K010642.md) | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedicals, Inc. | Mar 20, 2001 | SESE | | [K971753](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K971753.md) | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 | Denver Biomaterials, Inc. | Jun 27, 1997 | SESK | | [K803037](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM/K803037.md) | WILLIAM HARVEY VENTED MEDIASTINAL DRAIN | C.R. Bard, Inc. | Feb 4, 1981 | SESE | ## Top Applicants - Care Fusion — 4 clearances - Rocket Medical Plc — 3 clearances - Bearpac Medical — 2 clearances - C.R. Bard, Inc. — 2 clearances - Denver Biomedical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DWM) **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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