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FDA 510(k)

FLEXON TEMPORARY CARDIAC PACER LEAD

K-Number: K955722 · 1996-03-15

ApplicantDavis & Geck, Inc.
Decision Date1996-03-15
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXON TEMPORARY CARDIAC PACER LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Davis & Geck, Inc.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K955722. 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 FLEXON TEMPORARY CARDIAC PACER LEAD?

FLEXON TEMPORARY CARDIAC PACER LEAD is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Davis & Geck, Inc.. The 510(k) number is K955722.

When did FLEXON TEMPORARY CARDIAC PACER LEAD receive FDA 510(k) clearance?

FLEXON TEMPORARY CARDIAC PACER LEAD received FDA 510(k) clearance on 1996-03-15, under 510(k) number K955722.

Who is the listed applicant for FLEXON TEMPORARY CARDIAC PACER LEAD?

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

What is the FDA product code for FLEXON TEMPORARY CARDIAC PACER LEAD?

The FDA product code for FLEXON TEMPORARY CARDIAC PACER LEAD is LDF.

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Other records listing Davis & Geck, Inc. as applicant

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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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