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FDA 510(k)

ATRIAL J TEMPORARY PACING ELECTRODESS

K-Number: K821333 · 1982-06-02

ApplicantMedics Instrument Corp.
Decision Date1982-06-02
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIAL J TEMPORARY PACING ELECTRODESS is the device name listed in this FDA 510(k) record. The listed applicant is Medics Instrument Corp.. It received FDA 510(k) clearance on 1982-06-02 under 510(k) number K821333. 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 ATRIAL J TEMPORARY PACING ELECTRODESS?

ATRIAL J TEMPORARY PACING ELECTRODESS is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Medics Instrument Corp.. The 510(k) number is K821333.

When did ATRIAL J TEMPORARY PACING ELECTRODESS receive FDA 510(k) clearance?

ATRIAL J TEMPORARY PACING ELECTRODESS received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821333.

Who is the listed applicant for ATRIAL J TEMPORARY PACING ELECTRODESS?

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

What is the FDA product code for ATRIAL J TEMPORARY PACING ELECTRODESS?

The FDA product code for ATRIAL J TEMPORARY PACING ELECTRODESS is LDF.

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Other records listing Medics Instrument 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.

K905154GASTROSCANK903646GASTROGRAPHK812517CARDIAC PACING ELECTRODES

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

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