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FDA 510(k)

CARDIOVASCULAR TEMP. PACEMAKER ELEC

K-Number: K820003 · 1982-03-26

ApplicantDiag Corp.
Decision Date1982-03-26
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR TEMP. PACEMAKER ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Diag Corp.. It received FDA 510(k) clearance on 1982-03-26 under 510(k) number K820003. 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 CARDIOVASCULAR TEMP. PACEMAKER ELEC?

CARDIOVASCULAR TEMP. PACEMAKER ELEC is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Diag Corp.. The 510(k) number is K820003.

When did CARDIOVASCULAR TEMP. PACEMAKER ELEC receive FDA 510(k) clearance?

CARDIOVASCULAR TEMP. PACEMAKER ELEC received FDA 510(k) clearance on 1982-03-26, under 510(k) number K820003.

Who is the listed applicant for CARDIOVASCULAR TEMP. PACEMAKER ELEC?

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

What is the FDA product code for CARDIOVASCULAR TEMP. PACEMAKER ELEC?

The FDA product code for CARDIOVASCULAR TEMP. PACEMAKER ELEC is LDF.

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K984062SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229K911883DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCERK910645DISPOSABLE PATIENT CABLEK852446ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIPK820262PERMANENT & TEMPORARY PACEMAKER ELECTR.K812905PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

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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.

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