Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XEMEX TEMPORARY PACING CATHETER A

K-Number: K904868 · 1991-05-16

ApplicantZeon Medical Corp.
Decision Date1991-05-16
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XEMEX TEMPORARY PACING CATHETER A is the device name listed in this FDA 510(k) record. The listed applicant is Zeon Medical Corp.. It received FDA 510(k) clearance on 1991-05-16 under 510(k) number K904868. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XEMEX TEMPORARY PACING CATHETER A?

XEMEX TEMPORARY PACING CATHETER A is a medical device that received FDA 510(k) clearance on 1991-05-16. The listed applicant is Zeon Medical Corp.. The 510(k) number is K904868.

When did XEMEX TEMPORARY PACING CATHETER A receive FDA 510(k) clearance?

XEMEX TEMPORARY PACING CATHETER A received FDA 510(k) clearance on 1991-05-16, under 510(k) number K904868.

Who is the listed applicant for XEMEX TEMPORARY PACING CATHETER A?

The FDA 510(k) record lists Zeon Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XEMEX TEMPORARY PACING CATHETER A?

The FDA product code for XEMEX TEMPORARY PACING CATHETER A is LDF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Zeon Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K913521XEMEX TEMPORARY PACING CATHETER A MODIFIEDK905573XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A

Related Devices (Code: LDF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑