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FDA 510(k)

TRANSTHORACIC TEMP. PACEMAKER #100TPE

K-Number: K820232 · 1982-04-09

ApplicantTrans Pace, Inc.
Decision Date1982-04-09
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSTHORACIC TEMP. PACEMAKER #100TPE is the device name listed in this FDA 510(k) record. The listed applicant is Trans Pace, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820232. 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 TRANSTHORACIC TEMP. PACEMAKER #100TPE?

TRANSTHORACIC TEMP. PACEMAKER #100TPE is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Trans Pace, Inc.. The 510(k) number is K820232.

When did TRANSTHORACIC TEMP. PACEMAKER #100TPE receive FDA 510(k) clearance?

TRANSTHORACIC TEMP. PACEMAKER #100TPE received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820232.

Who is the listed applicant for TRANSTHORACIC TEMP. PACEMAKER #100TPE?

The FDA 510(k) record lists Trans Pace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSTHORACIC TEMP. PACEMAKER #100TPE?

The FDA product code for TRANSTHORACIC TEMP. PACEMAKER #100TPE is LDF.

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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

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

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