← Product Code [QJP](/productcode/QJP) · K261549 # BOBBY Balloon Guide Catheter (K261549) _MicroVention, Inc., d/b/a Terumo Neuro · QJP · Jun 9, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261549 ## Device Facts - **Applicant:** MicroVention, Inc., d/b/a Terumo Neuro - **Product Code:** [QJP](/productcode/QJP.md) - **Decision Date:** Jun 9, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. ## Device Story Co-axial, braid-reinforced, variable stiffness catheter; external hydrophilic coating; compliant balloon at distal end; bifurcated luer hub at proximal end. Operates by insertion into vasculature; balloon inflated/deflated via syringe with contrast media through co-axial outer lumen; inner lumen allows guidewire/catheter passage. Used in clinical settings (e.g., neurointerventional suites) by physicians. Radiopaque markers facilitate fluoroscopic visualization for positioning. Balloon provides temporary vascular occlusion; catheter acts as conduit for retrieval devices. Benefits include facilitated access to target vessels and controlled occlusion during procedures. ## Clinical Evidence No clinical data or animal testing was required. Substantial equivalence supported by bench testing, including simulated use, balloon burst/fatigue/compliance, kink resistance, torque strength, and leakage testing. All results met acceptance criteria. ## Technological Characteristics Materials: nylon, PTFE, polyethylene, polyolefin, stainless steel. Construction: co-axial, braid/coil reinforced shaft, compliant polyurethane balloon. Dimensions: 8Fr (0.110" OD), 6.5Fr (0.086" ID), 95 cm length. Connectivity: N/A. Sterilization: EtO (SAL 10^-6). ## Regulatory Identification A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. ## Predicate Devices - BOBBY Balloon Guide Catheter ([K193607](/device/K193607.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 9, 2026 MicroVention, Inc. d/b/a Terumo Neuro Miranda Beach Senior Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656 Re: K261549 Trade/Device Name: BOBBY Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: May 8, 2026 Received: May 11, 2026 Dear Miranda Beach: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261549 - Miranda Beach Page 2 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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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- {2} K261549 - Miranda Beach Page 3 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). Sincerely, NAIRA MURADYAN -S Naira Muradyan, PhD Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use 510(k) Number (if known) K261549 Device Name BOBBY Balloon Guide Catheter Indications for Use (Describe) The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} **TERUMO** NEURO ## 510(k) Summary **K261549** ### 510(k) Owner Information: 510(k) Owner: MicroVention, Inc. d/b/a Terumo Neuro Address: 35 Enterprise, Aliso Viejo, California 92656, USA Phone Number: (714)-247-8000 Contact Person: Miranda Beach Phone number: (949)-989-0580 **Date Prepared:** June 8, 2026 **Device Trade Name:** BOBBY™ Balloon Guide Catheter **Common Name:** Balloon Guide Catheter **Device Class:** Class II **Classification Name:** Percutaneous Catheter **Product Codes:** QJP, DQY **CFR Classification:** 21 CFR 870.1250 **Predicate Device:** BOBBY™ Balloon Guide Catheter (K193607) ### Indications for Use: The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. ### Device Description: The BOBBY™ Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. Both inflation lumen and guidewire lumen are constructed with a PTFE inner liner. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a 35 Enterprise, Aliso Viejo, CA 92656, USA terumoneuro.com Page 1 of 4 {5} hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position. ### **Comparison of Technological Characteristics:** The subject and predicate devices have the same intended use and fundamental technological characteristics. The device changes do not alter device dimensions, materials composition, or operating principle. | Feature | Predicate Device | Subject device | | --- | --- | --- | | | BOBBY Balloon Guide Catheter K193607 | BOBBY Balloon Guide Catheter K261549 | | FDA Classification | Class II | Same | | Product Code(s) | DQY, QJP | Same | | Regulation Number | 21 CFR 870.1250 | Same | | Regulation Name | Percutaneous Catheter | Same | | Indications for Use | The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. | Same | | Anatomical Locations | Peripheral and neuro vasculature | Same | | Materials | Commonly used medical grade plastics (e.g. nylon, PTFE, polyethylene, polyolefin) and stainless steel | Same | | Reinforced Catheter Shaft | Stainless steel braid and coil reinforced shaft | Same | | Injection Port | Yes | Same | | Radiopacity | Yes, shaft is visible due to distal tip Pt-Ir marker bands | Same | | Radiopaque Marker Bands | 2 | Same | | Compliant Balloon | Yes, polyurethane | Same | | Labeled Shaft Outer Diameter | 0.110 in (2.8 mm) 8Fr | Same | | Labeled Shaft Inner Diameter | 0.086 in (2.18 mm) 6.5Fr | Same | 35 Enterprise, Aliso Viejo, CA 92656, USA terumoneuro.com Page 2 of 4 {6} TERUMO NEURO | Feature | Predicate Device | Subject device | | --- | --- | --- | | | BOBBY Balloon Guide Catheter K193607 | BOBBY Balloon Guide Catheter K261549 | | Effective Length | 95 cm (37.4 in) | Same | | Tip Shape | Straight | Same | | Coating | Hydrophilic Coating – distal portion of shaft | Same | | Internal Construction | Coaxial lumen | Same | | Accessories Supplied | Peel Away Sheath | Same | | How Supplied | Sterile, single use | Same | | Sterilization Method | EtO | Same | | Sterility Assurance Level | 10^{-6} | Same | ### **Summary of Bench Testing:** Bench testing was conducted to demonstrate the subject device performs as intended and support substantial equivalence to the predicate device. All testing met previously established acceptance criteria or results were comparable to the predicate device. Testing included the following: - Simulated Use - Compatibility with Devices and Agents - Balloon Rated Burst - Balloon Inflation / Deflation Time - Balloon Fatigue - Balloon Decay - Atraumatic Tip and Flexible Distal Tip - Lumen Collapse During Aspiration - Kink Resistance - Force at Break - Freedom from Leakage – Liquid - Freedom from Leakage – Air - Dynamic Burst Pressure - Burst Pressure of Catheter - Flexural Fatigue - Balloon Compliance - Catheter Particle Testing - Torque Strength Testing 35 Enterprise, Aliso Viejo, CA 92656, USA terumoneuro.com Page 3 of 4 {7} **TERUMO** NEURO ### Animal Testing: An animal study was not deemed necessary to support the substantial equivalence of the subject device to the predicate device. ### Clinical Study: A clinical study was not deemed necessary to support the substantial equivalence of the subject device. ### Sterilization and Shelf Life: The subject device, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of $10^{-6}$ in accordance with ISO 11135. The modifications described in this submission do not impact sterilization as compared to the predicate device. The subject device’s shelf-life and packaging configuration remain identical to that of the predicate device. Therefore, no additional shelf life or packaging validation testing was required to demonstrate substantial equivalence between the subject and predicate device. ### Biocompatibility: The biological safety of the BOBBY Balloon Guide Catheter was established in accordance with the ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a Risk Management Process.” The balloon guide catheter is classified as an externally communicating device, circulating blood, limited contact ($\leq 24$ hrs.). The subject device does not introduce new materials or alter any patient-contacting surfaces. Materials of construction, sterilization method, sterility assurance level, and packaging configuration remain unchanged from the predicate device (K193607). Accordingly, no additional biocompatibility testing was conducted, and the previously established biocompatibility data remains applicable to the subject device. ### Conclusion: The subject BOBBY Balloon Guide Catheter has the same intended use and similar technological characteristics as the predicate device BOBBY Balloon Guide Catheter (K193607). The differences between the subject device and predicate device do not raise new questions of safety and effectiveness. The nonclinical performance testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate device. 35 Enterprise, Aliso Viejo, CA 92656, USA terumoneuro.com Page 4 of 4 --- **Source:** [https://fda.innolitics.com/device/K261549](https://fda.innolitics.com/device/K261549) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com