← Product Code [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN) · K972777 # TEMPORARY OCCLUSION BALLOON SYSTEM (K972777) _Percu Surge, Inc. · MJN · Mar 11, 1998 · Cardiovascular · SESU_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K972777 ## Device Facts - **Applicant:** Percu Surge, Inc. - **Product Code:** [MJN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN.md) - **Decision Date:** Mar 11, 1998 - **Decision:** SESU - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4450 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS). ## Device Story PercuSurge Temporary Occlusion Balloon (TOB) System is a catheter-based device used in peripheral vasculature. It facilitates localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion. Operated by clinicians in interventional procedures. Device provides localized delivery of fluids to target sites within peripheral vessels. Clinical benefit involves targeted treatment delivery while managing vessel flow. Safety and effectiveness not established for coronary, cerebral, or carotid use; specific warnings required regarding potential for death or permanent impairment if used in these contraindicated areas. ## Clinical Evidence No clinical data provided; safety and effectiveness in coronary, cerebral, or carotid vasculature have not been established. ## Regulatory Identification A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. ## 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. SEP 22 199 . . Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Debora D. Hinman Ms. Be Director, Regulatory Affairs PercuSurge Incorporated 777 N. Pastoria Avenue Sunnyvale, CA 94086 K972777 NSE Appeal Re : Appeal PercuSurge Temporary Occlusion Balloon (TOB) System Trade Name: Regulatory Class: II MJN Product Code: Dated: May 20, 1998 Received: May 21, 1998 Received. May 21, June 29, and August 5, 1998 Dear Ms. Hinman: We have reviewed your Section 510(k) notification of intent to market we nave reviewed your becaused and we have determined the device is the device reletenced above and will ations for use stated in the substantial enclosure) to legally marketed predicate devices marketed in enclobure) Co regally marketed provent date bays boon reclargified Medical Device Amendments, or to devices that have been reclassified Medical Device Imendance, with Federal Food, Drug, and In accordance with the provisione of therefore, market the device, subject to the general controls provisions of the Act and the limitations the general controls provisions of the Act include described befor - The generation, listing of devices, good requirements for annual regenting, and prohibitions against misbranding and adulteration. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could Therefore, in accordance with Section 513(i)(1)(E) of the cause harm. Act, the following limitation must appear in the Indications and Warnings section of the device's labeling: {1}------------------------------------------------ ## Page 2 - Debora D. Hinman ## INDICATIONS AND INTENDED USE: 1. The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS). In bold and first to appear in the WARNINGS section, 2. WARNINGS : . The safety and effectiveness of the PercuSurge Temporary Occlusion Balloon (TOB) System, used as an adjunct in interventional procedures, have NOT been established. Complications from the use of the device in this manner could lead to death, permanent impairment, and/or the need for emergency surgical intervention. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) 2 {2}------------------------------------------------ Page 3 - Debora D. Hinman premarket notification if the limitation statement above is added to your labeling, as described. Please note that the above labeling limitations are required by Please note that the above fame act. Therefore, a new 510 (k) is required Section 513(1) (1) (1) or the xec. " increases, and on removed from the device's labeling. If you desire specific information about the application of other If you desire specific information and in the part 801 and additionally labeling requirements to your device (21 CFF Part on the Office of labeling requirements to your actives), please contact the Office of 809.10 for in vitro diagnostic devices), for questions on the 809.10 for in Victo dragable additionally, for questions on the Compliance at (301) 594-4040. Thateban, please contact the office of promotion and advertising or four as please note the regulation Compilance at (301) 594 1059. entitled, "Misbranding by reference to premarket notification" (21 CFR) "Misbranding by rereaches on your responsibilities under the 807.97). 807.97). Ocher general Inhostivision of Small Manufacturers Assistance at its toll the bring (800) 638-2041 or (301) 443-6597 of Assistance at Ics Corr-Liec namber (600) (600) cdrh/dsma/dsmamain.html". at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Phing & Chitizer Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 4 - Debora D. Hinman Page 1 of 1 . 510(k) Number (if known): K972777 Device Name: PercuSurge Temporary Occlusion Balloon (TOB) System__ FDA's Statement of the Indications For Use for device: OR The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS). Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K972777](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJN/K972777) **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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