← Product Code [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO) · K970854 # 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER (K970854) _Cordis Corp. · DQO · Sep 30, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K970854 ## Device Facts - **Applicant:** Cordis Corp. - **Product Code:** [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO.md) - **Decision Date:** Sep 30, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1200 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. ## Device Story The Infiniti® Angiographic Catheters are vascular access devices used to deliver radiopaque contrast media to specific sites within the vascular system. The device consists of a braided proximal shaft and various tip configurations, available in 5 F and 6 F diameters. It is operated by a physician in a clinical setting (e.g., catheterization lab) to facilitate diagnostic imaging. The catheter is inserted into the vasculature to allow for the targeted injection of contrast agents, which enhances the visibility of blood vessels during fluoroscopic or radiographic procedures, aiding in clinical diagnosis and decision-making. ## Clinical Evidence No clinical data provided. Biocompatibility testing was based on previously cleared devices. ## Technological Characteristics Catheter diameters of 5 F and 6 F; braided proximal shaft; various tip configurations. Materials previously validated for biocompatibility in predicate devices. ## Regulatory Identification An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. ## Predicate Devices - 4 F Infiniti® Angiographic Catheter ([K960975](/device/K960975.md)) - 6 F Paragon (Infiniti®) Angiographic Catheter ([K921310](/device/K921310.md)/A) ## 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} 00-00034 K970854 SEP 30 1997 # PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification # SUMMARY OF SAFETY AND EFFECTIVENESS ## I. General Provisions Common or Usual Name: Angiographic Catheter Proprietary Name: Cordis 5 F Infiniti® Angiographic Catheter Cordis 6 F Infiniti® Angiographic Catheter ## II. Name of Predicate Devices 4 F Infiniti® Angiographic Catheter, K960975, April 02, 1996 6 F Paragon (Infiniti®) Angiographic Catheter, K921310/A, Sept. 17, 1992 ## III. Classification Class II ## IV. Performance Standards Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. ## V. Intended Use and Device Description The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations. ## VI. Biocompatibility All appropriate biocompatibility tests were previously performed on the materials used for the 5 F and 6 F Infiniti® Angiographic Catheters. No new tests were performed, since all materials had been successfully tested on previously concurred devices. {1} 00-00035 PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification ## VII. Summary of Substantial Equivalence The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially angiographic catheters. {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Elena S. Jugo, M.D. Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700 SEP 30 1997 Re: K970854 5 Fr and 6 Fr Infiniti® Angiographic Catheters Regulatory Class: II (two) Product Code: DQO Dated: July 2, 1997 Received: July 3, 1997 Dear Dr. Jugo: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 to 895. A substantially equivalent determination assumes compliance 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 regulatory 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. {3} This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} 00-0005 # PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification 510(k) Number (if known): K970854 Device Name: 5 F and 6 F Infiniti® Angiographic Catheters Indications for Use: Cordis Angiographic Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-0.jpeg](img-0.jpeg) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K970854](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K970854) **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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