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FDA 510(k)

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD

K-Number: K924388 · 1993-10-21

ApplicantAngemed, Inc.
Decision Date1993-10-21
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Angemed, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K924388. 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 ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD?

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Angemed, Inc.. The 510(k) number is K924388.

When did ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD receive FDA 510(k) clearance?

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD received FDA 510(k) clearance on 1993-10-21, under 510(k) number K924388.

Who is the listed applicant for ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD?

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

What is the FDA product code for ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD?

The FDA product code for ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD is LDF.

Related Clinical Trials

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.

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Other records listing Angemed, Inc. 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.

K924390ANGEMED 5000 LEAD ADAPTER

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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