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FDA 510(k)

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD

K-Number: K012452 · 2001-08-14

ApplicantMedtronic Vascular
Decision Date2001-08-14
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K012452. 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 MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD?

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Medtronic Vascular. The 510(k) number is K012452.

When did MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD receive FDA 510(k) clearance?

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD received FDA 510(k) clearance on 2001-08-14, under 510(k) number K012452.

Who is the listed applicant for MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD?

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

What is the FDA product code for MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD?

The FDA product code for MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD 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

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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