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FDA 510(k)

EXTERNAL PACEMAKER WIRE DRESSING CHANGE

K-Number: K881356 · 1988-05-19

ApplicantNeal & Assoc., Inc.
Decision Date1988-05-19
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PACEMAKER WIRE DRESSING CHANGE is the device name listed in this FDA 510(k) record. The listed applicant is Neal & Assoc., Inc.. It received FDA 510(k) clearance on 1988-05-19 under 510(k) number K881356. 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 EXTERNAL PACEMAKER WIRE DRESSING CHANGE?

EXTERNAL PACEMAKER WIRE DRESSING CHANGE is a medical device that received FDA 510(k) clearance on 1988-05-19. The listed applicant is Neal & Assoc., Inc.. The 510(k) number is K881356.

When did EXTERNAL PACEMAKER WIRE DRESSING CHANGE receive FDA 510(k) clearance?

EXTERNAL PACEMAKER WIRE DRESSING CHANGE received FDA 510(k) clearance on 1988-05-19, under 510(k) number K881356.

Who is the listed applicant for EXTERNAL PACEMAKER WIRE DRESSING CHANGE?

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

What is the FDA product code for EXTERNAL PACEMAKER WIRE DRESSING CHANGE?

The FDA product code for EXTERNAL PACEMAKER WIRE DRESSING CHANGE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neal & Assoc., 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.

K925924NEAL WRIST CONES

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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