Bio-Medicus Life Support Catheter and Introducer

K251831 · Medtronic, Inc. · QHW · Jan 15, 2026 · Cardiovascular

Device Facts

Record IDK251831
Device NameBio-Medicus Life Support Catheter and Introducer
ApplicantMedtronic, Inc.
Product CodeQHW · Cardiovascular
Decision DateJan 15, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4100
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours. Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Device Story

Single-lumen peripheral-access catheter and introducer; used for blood drainage or reinfusion in extracorporeal circuits (CPB, ECMO, ECLS). Introducer facilitates placement over guidewire. Used in clinical settings (e.g., OR, ICU) by trained medical professionals. Device connects to extracorporeal circuit; provides vascular access for life support. Benefits include enabling perfusion of vessels/organs during critical respiratory or cardiopulmonary failure. Modifications from predicate include material formulation changes (catheter body, hemostasis cap), removal of encapsulated urethane layer, updated reinforcement geometry (holes vs. slots), and modified introducer taper angles and barbed connectors.

Clinical Evidence

Bench testing only. No clinical data. Performance demonstrated via bench testing, mechanical integrity, durability, and reliability testing. Biocompatibility assessed per ISO 10993-1:2018. In vivo evaluation performed over 7-day duration. Compliance with ISO 18193:2021 confirmed.

Technological Characteristics

Single-lumen peripheral-access catheter; materials include urethane-based components. Features include barbed connectors, hemostasis cap, and reinforced catheter body. Sterilized, single-use, disposable. Compatible with extracorporeal circuits. Design parameters consistent with 21 CFR 870.4100 special controls.

Indications for Use

Indicated for adult and pediatric patients requiring extracorporeal cardiopulmonary bypass (CPB) for up to 6 hours, or ECMO/ECLS for acute respiratory or cardiopulmonary failure where other treatments failed and death is imminent. Contraindicated in vessels with arterial dissection or severe peripheral atherosclerosis.

Regulatory Classification

Identification

An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible; (2) The devices and accessories in the circuit must be demonstrated to be biocompatible; (3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories; (4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability; (5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and (6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 15, 2026 Medtronic Inc Elizabeth Rose Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112 Re: K251831 Trade/Device Name: Bio-Medicus Life Support Catheter and Introducer Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: QHW, DWF Dated: December 8, 2025 Received: December 8, 2025 Dear Elizabeth Rose: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251831 - Elizabeth Rose Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K251831 - Elizabeth Rose Page 3 Sincerely, **Meaghan Erlewein -S** For Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K251831 Device Name Bio-Medicus Life Support Catheter and Introducer Indications for Use (Describe) Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours. Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov > "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} 510(k) Summary Date Prepared: January 15, 2026 Submission Number: K251831 Applicant: Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 Contact Person: Elizabeth Rose Regulatory Affairs Specialist Phone: (423) 252-9924 Email: elizabeth.m.rose@medtronic.com Kimberly Peterson (Alternate) Director, Regulatory Affairs Phone: (763) 526-6751 Email: kimberly.m.peterson@medtronic.com Trade Name: Bio-Medicus Life Support Catheter and Introducer Common Name: Extracorporeal Life Support Single Lumen Catheter Classification Name: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure Classification: Class II (with special controls) Regulation Number: 21 CFR 870.4100 Product Code: QHW, DWF Predicate Device: Bio-Medicus Life Support Catheter and Introducer Predicate 510(k) Number: K201057, cleared January 14, 2022 K201100, cleared July 15, 2021 Common Name: Extracorporeal Life Support Single Lumen Catheter Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Classification: Class II Regulation Number: 21 CFR 870.4100 {5} Product Code: DWF Reference Device: Crescent Jugular Dual Lumen Catheter Reference 510(k) Number: K203409 Common Name: Extracorporeal Life Support Single Lumen Catheter Classification Name: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure Classification: Class II (with special controls) Regulation Number: 21 CFR 870.4100 Product Code: PZS # Device Description The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters. These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25°C (77°F). Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. # Indications for Use Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours. Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. {6} # Contraindications Alone, the catheter and introducer are not medical treatment devices. The introducer is to be used only with the appropriately sized Bio-Medicus Life Support catheter. These devices are intended for use only as indicated in these instructions for use. Do not insert the catheter in a vessel that has arterial dissection or severe peripheral atherosclerosis. # Substantial Equivalence Substantial equivalence analysis includes both comparison to the predicate device and clinically relevant reference devices. The Bio-Medicus Life Support Catheter and Introducer design, principles of operation, and fundamental scientific technology are substantially equivalent to the primary predicate device, Bio-Medicus Life Support Catheter and Introducer (K201057 and K201100) # Comparison to Predicate A comparison of the modified devices to the currently marketed predicate device (K201057, K201100) and reference device (K203409) indicates the subject devices are substantially equivalent with the following similarities: - Same intended use - Same operating principle - Same device design - Same material type - Same packaging materials and design - Same sterilization requirements, methods, and parameters - Same shelf life The following device modification was made to the predicate device: - Catheter body material formulation change - Hemostasis cap material formulation change - Body Layer - No Encapsulated Urethane Layer - Encapsulated catheter body reinforcements visual appearance to holes - Introducer Taper Angle (Mini catheters only) to 6 degrees - Barbed Connector 3/8" (utilizing the reference device component) - Barbed Connector 3/8" w/Luer Port (utilizing the reference device component) - Barbed Connector 1/4" (utilizing the reference device component) The Bio-Medicus Life Support Catheter and Introducer device meets all special controls identified in 21 CFR 870.4100, as follows: {7} - Technological Characteristics: The geometry and design parameters of the subject device are consistent with the device's intended use in extracorporeal support procedures, and the device is compatible with the other devices and accessories in the extracorporeal circuit. - Biocompatibility: The subject device is demonstrated to be biocompatible as a prolonged use device in accordance with ISO 10993-1:2018 and with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (8 September 2023). - Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing demonstrate that the subject device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device. - Non-clinical Performance: Substantial equivalence of the performance characteristics is demonstrated on bench, mechanical integrity, durability, and reliability testing. - In vivo Evaluation: In vivo evaluation demonstrates the subject device's performance over a 7-day duration of use. - Labeling: The Instructions for Use include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the device in an extracorporeal circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure. # Summary of Performance Data Testing has demonstrated the Bio-Medicus Life-Support Catheter and Introducers are substantially equivalent to the predicate device and comply with ISO 18193:2021 – Cardiovascular Implants and Artificial Organs — Cannulae for Extracorporeal Circulation. The tests summarized in Table 1 were conducted to demonstrate substantial equivalence of the proposed device to the predicate device. Table 1: Summary of Changes from Predicate Device | Component | Material Change | Design Verification and Validation | Results | | --- | --- | --- | --- | | Catheter Body | The catheter body has undergone a material formulation change. | Risk-based testing and evaluations to qualify this change included product functional testing and biocompatibility assessment. | Pass | | Hemostasis cap | The hemostasis cap has undergone a supplier and material formulation change. The new hemostasis cap is currently used on the reference device. | Risk-based testing and evaluations to qualify this change included product functional testing and biocompatibility assessment. | Pass | | Body layer | The body layer has undergone a modification to remove the encapsulated urethane layer. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | {8} Table 1: Summary of Changes from Predicate Device | Component | Material Change | Design Verification and Validation | Results | | --- | --- | --- | --- | | Encapsulated catheter body reinforcements visual appearance | The catheter body reinforcements has undergone a modification to change from radial slots to holes. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | | Introducer Taper Angle (Mini catheters) | The introducer taper angle has undergone a modification, only applicable to the min catheters, to change the angle to 6 degrees. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | | Mini Drainage Catheter Tip Reinforcement | The mini drainage catheter tip reinforcement has undergone a modification to change to a 1 piece spaced reinforcement. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | | Barbed Connector 3/8" (Flex XL, Multi, Multi XL, only) | The barbed connector has undergone a modification to use the same connector used on the reference device. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | | Barbed Connector 3/8" w/Luer Port (Flex, only) | The barbed connector with leur port has undergone a modification to use a modified version of the 3/8" barbed connector used on the reference device. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | | Barbed Connector 1/4" (Mini Drainage and Mini Return, only) | The barbed connector has undergone a modification to use the same connector used on the reference device. | Risk-based testing and evaluations to qualify this change included product functional testing. | Pass | # Conclusion The information included in this submission demonstrates that the modified Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate device, Bio-Medicus Life Support Catheter and Introducer (K201057, K201100).
Innolitics
510(k) Summary
Decision Summary
Classification Order
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