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)

TEMP. BIPOLAR EPICARDIAL LEAD

K-Number: K831645 · 1983-07-26

ApplicantCordic Corp.
Decision Date1983-07-26
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMP. BIPOLAR EPICARDIAL LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Cordic Corp.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831645. 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 TEMP. BIPOLAR EPICARDIAL LEAD?

TEMP. BIPOLAR EPICARDIAL LEAD is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Cordic Corp.. The 510(k) number is K831645.

When did TEMP. BIPOLAR EPICARDIAL LEAD receive FDA 510(k) clearance?

TEMP. BIPOLAR EPICARDIAL LEAD received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831645.

Who is the listed applicant for TEMP. BIPOLAR EPICARDIAL LEAD?

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

What is the FDA product code for TEMP. BIPOLAR EPICARDIAL LEAD?

The FDA product code for TEMP. BIPOLAR EPICARDIAL LEAD 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

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.

↑