← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K030852 # 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX (K030852) _Mogul Enterprises · DRF · Jul 10, 2003 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K030852 ## Device Facts - **Applicant:** Mogul Enterprises - **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md) - **Decision Date:** Jul 10, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1220 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Intended Use The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study. ## Device Story EP Diagnostic Catheters (Astra 1 and Astra II) are diagnostic tools used by electrophysiologists during cardiac electrophysiology studies. The catheters are inserted into the heart to record electrical signals (electrograms) and provide cardiac stimulation. These inputs allow clinicians to map cardiac electrical activity and diagnose arrhythmias. The device is used in a clinical or hospital setting. By facilitating precise signal acquisition and stimulation, the catheters assist in identifying the origin and mechanism of cardiac rhythm disorders, enabling targeted clinical decision-making and therapeutic planning. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Electrode recording catheter; 4 French and 5 French diameters; used for electrogram recording and cardiac stimulation. No specific materials or software algorithms described. ## 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. ## Related Devices - [K022380](/device/K022380.md) — LIVESIRE ELECTROPHYSIOLOGY CATHETER · St Jude Medical · Oct 1, 2002 - [K993698](/device/K993698.md) — SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX · Mogul Enterprises · Aug 16, 2000 - [K984150](/device/K984150.md) — PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER · Ep Medsystems · Feb 22, 1999 - [K162892](/device/K162892.md) — Achieve Advance Mapping Catheter · Medtronic, Inc. · Nov 15, 2016 - [K211327](/device/K211327.md) — Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters · CathRx, Ltd. · Feb 10, 2022 ## Submission Summary (Full Text) {0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows a circular seal with the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers. The seal appears to be a logo or emblem, possibly representing a government agency or organization related to health and human services in the United States. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 1 0 2003 Mogul Enterprises, Inc. c/o Mr. Jamil Mogul CEO/Chairperson 6387 San Ignacio Avenue San Jose, CA 95119 Re: K030852 > Trade Name: EP Diagnostic Catheters, Models Astra™ 1 and Astra™ II Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: June 9, 2003 Received: June 10, 2003 Dear Mr. Mogul: 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. {1}------------------------------------------------ Page 2 - Mr. Jamil Mogul 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours, 1. XQeTeh Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 030852 ## 3.0 Intended Use The modified device has the same intended use as that of the FDA-cleared (unmodified) device, which is as follows: "The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study." Prescription Use \$\checkmark\$ Ndelettm Special 510(k): Device Modification Application 4 French & 5 French Electrophysiology Diagnostic Catheters MOGUL ENTERPRISES, Inc. 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