← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K024058 # MODIFICATION TO CARDEON AEGIS CATHETER (K024058) _Cardeon Corp. · DWF · Dec 30, 2002 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K024058 ## Device Facts - **Applicant:** Cardeon Corp. - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Dec 30, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. ## Device Story Aegis Catheter is a vascular cannula used to perfuse the aorta during open chest cardiac surgery. It connects to the extracorporeal circuit to return blood flow to the patient. Used in the operating room by surgeons; it facilitates cardiopulmonary bypass by providing directed arterial return. The device is designed for short-term use (up to 6 hours). It functions as a conduit for blood return, ensuring adequate perfusion during the procedure. ## Clinical Evidence Bench testing only. Biocompatibility, in vitro, and in vivo performance testing were conducted to demonstrate safety and effectiveness equivalent to previously approved devices. ## Technological Characteristics Vascular catheter/cannula for cardiopulmonary bypass. Features directed flow (specified flow pattern) for arterial return. Designed for connection to standard extracorporeal circuits. Class II device (Product Code DWF). ## Regulatory Identification A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. ## 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}------------------------------------------------ KC24058 DEC 3 0 2002 ## 510(k) SUMMARY ## 510(k) number: This summary of information is being provided for the modified Aegis Catheter in accordance with 21 CFR 807.92(a). | Applicant Information: | Cardeon Corporation 10161 Bubb Road Cupertino, CA 95014 | |------------------------|-----------------------------------------------------------| | Contact Person: | Jane Beggs Regulatory Affairs Cardeon Corporation | | Date: | 6 December 2002 | | Device Trade Name: | Cardeon® Aegis™ Catheter | | Device Common Name | Catheter, cannula and tubing, vascular, cardiopulmonary | | Regulation No.: | bypass 870.4210 | | Classification / Code: | Class II / DWF | Indications for Use: The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The modified Aegis Catheter is substantially Summary of Substantial Equivalence: equivalent to the original Aegis Catheter and currently marketed devices with regard to intended use/indications, device performance and technological characteristics. These devices are used to directly cannulate the aorta and return perfusion to patients undergoing general cardiac surgery through standard connections to the extracorporeal circuit. Substantial equivalence is supported through comparison with several marketed devices with the same indications for use, including arterial return cannulae with directed flow (specified flow pattern). Differences between the Aegis Catheter and other devices do not alter or diminish the rate of arterial return required during cardiopulmonary bypass. Based on comparisons to premarket devices, the modified Aegis Catheter is substantially equivalent to the original Aegis Catheter and currently marketed devices. Product Testing: The determination of substantial equivalence was also based on tests of biocompatibility, in vitro and/or in vivo performance conducted for the original and modified Aegis devices. Results of product testing demonstrated that the modified Aegis Catheter functions as safely and effectively as previously approved devices. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 3 0 2002 Cardeon Corporation c/o Ms. Jane Beggs Vice President, Regulatory Affairs 10161 Budd Road Cupertino, CA 95014 Re: K024058 Trade Name: Cardeon® Aegis™ Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Vascular Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: December 6, 2002 Received: December 9, 2002 Dear Ms. Beggs: 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. Iisting 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. Jane Beggs 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 (OS) 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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. W. Dalton Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ . Page 1 of 1 Device Name: Cardeon® Aegis™ Catheter Indications for Use: : The Cardeon Aegis™ Catheter is intended to perfuse the aorta during open chest procedures on cardiopulmonary bypass up to 6 hours. Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | X | OR | Over-the Counter Use | | |------------------|---|----|----------------------|--| |------------------|---|----|----------------------|--| (Division Sign-Off) Division of Cardiovascular and Respiratory Devices | 510(k) Number | K024058 | |---------------|---------| |---------------|---------| --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K024058](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K024058) **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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