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FDA 510(k)

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE

K-Number: K032613 · 2003-11-20

ApplicantPeter M. Rothenberg, M.D.
Decision Date2003-11-20
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Peter M. Rothenberg, M.D.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K032613. 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 TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE?

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Peter M. Rothenberg, M.D.. The 510(k) number is K032613.

When did TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE receive FDA 510(k) clearance?

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE received FDA 510(k) clearance on 2003-11-20, under 510(k) number K032613.

Who is the listed applicant for TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE?

The FDA 510(k) record lists Peter M. Rothenberg, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE?

The FDA product code for TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE 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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