← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K080206 # MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (K080206) _Radi Medical Systems AB · DXC · Feb 26, 2008 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K080206 ## Device Facts - **Applicant:** Radi Medical Systems AB - **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md) - **Decision Date:** Feb 26, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.4450 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use FemoStop® Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation, and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm. ## Device Story FemoStop® Gold Femoral Compression System is a mechanical compression device used in clinical settings to induce hemostasis at femoral vessel puncture sites. The system comprises an arch, a sterile pneumatic pressure dome, a belt, a hemostatic dressing, and an integrated pump with a digital manometer. The clinician places the dome over the puncture site and secures the belt around the patient; the pump and manometer allow the clinician to control and monitor the mechanical pressure applied by the dome. The arch and belt provide necessary counter-pressure. The device facilitates hemostasis post-cannulation and assists in the repair of pseudoaneurysms. By providing controlled, localized pressure, the device aids in preventing bleeding complications, benefiting patients undergoing vascular procedures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical vascular clamp system consisting of an arch, pneumatic pressure dome, belt, and hemostatic dressing. Features an integrated single-use digital pump and manometer for pressure control. Operates via mechanical compression. No specific material standards or software architecture details provided. ## Regulatory Identification A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. ## Predicate Devices - FemoStop® HD Femoral Compression System ([K024107](/device/K024107.md)) - BP101 Digital Blood Pressure Monitor ([K062033](/device/K062033.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}------------------------------------------------ FEE 26 8 ## 510(k) Summary 5 | Submitter's information: | Radi Medical Systems AB
Palmbladsgatan 10
SE-754 50 Uppsala, Sweden
Phone:(+46) 18161000 | |--------------------------|---------------------------------------------------------------------------------------------------| | Contact Person: | Helene Ekstrand | | Date Prepared: | January 23rd, 2008 | | Proprietary Name: | FemoStop® Femoral Compression System | | Regulation Name: | Vascular clamp | | Product code: | DXC | | Predicate Devices: | K024107 FemoStop® HD Femoral Compression System
K062033 BP101 Digital Blood Pressure Monitor | Description of the Device: This combination of FemoStop®Femoral Compression System consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer, a belt and a hemostatic dressing and is called FemoStop®Gold Femoral Compression System. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The pressure of the dome is controlled by the integrated pump and the manometer. The arch and belt provide counter pressure for the dome. The sterile hemostatic dressing is placed on the skin incision site as a bacterial barrier and for topical control of bleeding, Indication for Use of the Device: FemoStop® Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation, and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm. Technical Characteristics: The technical characteristics of the actual FemoStop® are identical to those of the predicate FemoStop®Femoral Compression System except for the integration of a single-use digital pump. {1}------------------------------------------------ Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 6 2008 Radi Medical Systems AB c/o Ms. Helene Ekstrand Regulatory Affairs Officer Palmbladsgatan 10 SE-75450 Uppsala Sweden Re: K080206 Femostop Femoral Compression System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: January 23, 2008 Received: January 28, 2008 Dear Ms. Ekstrand: 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 (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. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2 - Ms. Helene Ekstrand 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Duna R. Vacher Image /page/2/Picture/5 description: The image shows a black and white abstract drawing. The drawing appears to be a stylized signature or symbol. It consists of curved lines and a sharp angle at the bottom, resembling a simplified letter or character. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 4 510(k) Number: Device Name: K080206 FemoStop® Femoral Compression System Indications for Use: FemoStop® Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm . Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ume R. Vi Ames (Division Sign-Off) Division of Cardiovascular Devices 510(к) Number_KO8020 6 Page 1 of 1 7 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K080206](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K080206) **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