← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K955847 # GYRO TIP EP CATHETER (K955847) _Cardiac Assist Devices, Inc. · DRF · Jan 29, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K955847 ## Device Facts - **Applicant:** Cardiac Assist Devices, Inc. - **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md) - **Decision Date:** Jan 29, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1220 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use Monitor and record intra-cardiac electrical activities ## Device Story Gyro Tip EP Catheter is a deflectable tip recording catheter used for monitoring and recording intra-cardiac electrical activities. Operated by physicians in clinical settings, the device is inserted into the heart to capture electrical signals. These signals are transmitted to external recording equipment, allowing clinicians to visualize cardiac electrical activity, diagnose arrhythmias, and guide clinical decision-making during electrophysiological procedures. The deflectable tip mechanism allows for precise positioning within the cardiac chambers to optimize signal acquisition. ## Clinical Evidence Bench testing only; includes electrical and mechanical performance testing and material biocompatibility assessment. ## Technological Characteristics Deflectable tip electrode recording catheter. Class II device per 21CFR870.1280. Features include mechanical tip deflection mechanism for positioning. Biocompatible materials used. No established performance standards. ## Regulatory Identification An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations. ## Predicate Devices - Bard Dynamic Tip Catheter ([K912213](/device/K912213.md)) - Bard Tip Deflecting Catheter ([K904080](/device/K904080.md)) - Bard Tip Deflecting Electrode Catheter ([K891908](/device/K891908.md)) - Steerocath ([K900765](/device/K900765.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} Cardiac Assist Devices, Inc. 11000 Cedar Ave. Suite # 451 Cleveland, Ohio 44106-3052 Phone: (216) 791-2234 Fax: (216) 281-4639 JAN 29 1997 Premarket Notification 510(k) Device: Gyro Tip EP Catheter Device Class: II K955847 # December 18, 1995 Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate BLVD. Rockville, Maryland 20850 # The Safe Medical Device Act Summary RE: Premarket Notification for Gyro Tip EP Catheter This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. In accordance with Section 510(K) of the Federal Food, Drug and Cosmetic Act, notification is hereby made of the intention of the Cardiac Assist Devices, Inc. to market the following device: 1. Device Name: Gyro Tip EP Catheter Classification Name: Electrode Recording Catheter Common Name: Deflectable Tip Recording Catheter Trade Name: Gyro Tip EP Catheter Intended Use: Monitor and record intra-cardiac electrical activities 2. Cardiac Assist Devices, Inc. has submitted form FDA-2891 (Initial Registration of Medical Device Establishment) for its manufacturing facility located at 11000 Cedar Ave. Suite 451, Cleveland, Ohio 44106-3052, to FDA. 3. Classification: Electrode Recording Catheters have been officially classified as CLASS II as described in 21CFR870.1280 (1) {1} Cardiac Assist Devices, Inc. 11000 Cedar Ave. Suite # 451 Cleveland, Ohio 44106-3052 Phone: (216) 791-2234 Fax: (216) 281-4639 Premarket Notification 510(k) Device: Gyro Tip EP Catheter Device Class: II # The Safe Medical Device Act Summary (continue) 4. Performance Standards: None Established 5. Draft Labelling of the Gyro Tip EP Catheter is presented in Section 9 of this document. This Draft Labeling includes: Direction for Use, Indications, Cautions, Description, Warnings and Precautions. 6. Substantial Equivalence: The Gyro Tip EP Catheter is substantially equivalent to Bard Dynamic Tip Catheter (K912213), Bard Tip Deflecting Catheter (K904080), Bard Tip Deflecting Electrode Catheter (K891908), and Steerocath (K900765). Section 4 of this document contains a detailed statement of substantial equivalence. 7. Section 1 (Executive Summary) of this document is a more comprehensive summary statement that includes additional information regarding the material biocompatibility, physical characteristics, results of electrical and mechanical tests and a general description of the Gyro Tip EP Catheter. If you have any questions or require any additional information regarding the content of this document, please call me at (216) 791-2234 or fax to: (216) 281-4639. Sincerely yours, *Rassoll Rashidi* Rassoll Rashidi, BME. President (2) --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K955847](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K955847) **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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